<h3>Job Description</h3>
Salary: $95,000 - $115,000
We are looking for an experienced Sr. Clinical Operations Manager, Business Development to join our team! 

Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!
Senior Clinical Operations Manager, Business Development serves as the primary point of contact for new study proposals, existing study change requests, and ongoing oversight of proposal, budget, and contracting timelines. In addition, this position may support industry sponsored clinical trials, Endpoint and Specialty Services activities, as well as any additional assigned projects.
Business Development Responsibilities:

<ul>
<li>Serve as primary point of contact for new study and consulting proposals; coordinate with internal teams to prepare responses to proposals including project budgets. </li>
<li>Develop and manage proposal specific timelines to ensure timely delivery of responses to clients and internal CPC team members. </li>
<li>Serve as primary point of contact for the internal CPC teams to address questions about contracted scope, budget amendments, budgeted task inclusions, etc. </li>
<li>Help maintain, or develop where needed,standard materials and templates for responses to proposals, bid defenses, capabilities discussions, etc. based on different business lines within CPC.  </li>
<li>Work closely with Legal Affairs to ensure confidentiality agreements are in place with new partners prior to dissemination of confidential information.</li>
<li>Coordinate the process for obtaining  quotes from vendors as requested by the CPC project team, or as needed to complete a new proposal budget. </li>
<li>Facilitate scheduling of external meetings to review proposal requests, budget questions, capabilities presentations, etc. </li>
</ul>
Clinical Research Responsibilities:

<ul>
<li>Work closely with the Director of Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.</li>
<li>Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.</li>
<li>Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM).  For single-site or smaller multi-center studies in which these activities are not delegated to a CTM:</li>
</ul>

* Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.
* Identify the required regulatory documents for investigational product (IP) release and oversee documents collection. 
* Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.
* Oversee the development of project-specific essential documents for site oversight and development of site materials.
* Review and finalize monitoring visit reports and follow-up letters with Clinical Research Associates (CRAs).
* Work with CRAs on overall site management including identification, and resolution of site related compliance issues. 
* Prepare study enrollment reports and review site issues with the project team.
* Manage and approve site payments as applicable.

<ul>
<li>Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.</li>
<li>Define and monitor project scope, timelines and deliverables from project initiation to close-out in collaboration with the Head of Research and Community Health Operations. </li>
<li>Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.</li>
<li>Oversee trial-related activities and provide performance feedback to supervisors for all project team members.</li>
<li>Participate in the review, development and testing of study databases.</li>
<li>Provide investigational product or device tracking and disposition as required by project.</li>
<li>Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services.  </li>
<li>Identify vendors and manage vendor services.</li>
<li>Provide expert advice in the design, writing and/or review of all project-related essential documents including protocols, project management plans, case report forms, statistical analysis plans, project management plans, ICF templates, study procedure manuals, source documents, site newsletters, study reports, resource tools, monitoring plans and report templates. </li>
<li>Develop and manage multidisciplinary project team members. Organize, plan for, and produce minutes for project team meetings.</li>
<li>Proactively identify project issues, propose resolutions to the project team, applicable heads of departments, CPC executives and/or the sponsor, and then track implementation of resolution through to completion and efficacy checks.</li>
<li>Ensure the overall quality of project services and deliverables.</li>
<li>Provide necessary updates and reports to the sponsor as outlined by the contract.</li>
<li>Plan and oversee the execution of investigator meetings as contracted.</li>
<li>Work with the business development team on budgets, proposals and change orders.</li>
<li>Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements.</li>
<li>Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. Provide timely feedback to the Head of Research and Community Health Operations on the progress of project assignments. Routinely advise management regarding the overall project status.</li>
<li>Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper.  </li>
<li>Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). Use appropriate discretion to proactively identify when there is a need to deviate from policies, procedures or plans and ensure deviations are appropriately documented.</li>
<li>Supervise and evaluate performance of all staff reporting to this position, if applicable.</li>
<li>Additional activities as required.</li>
</ul>
Qualifications:

<ul>
<li>A Nursing or BA/BS in a scientific field (or equivalent knowledge/experience).</li>
<li>5 years of experience in a clinical research setting (required).</li>
<li>3 years of sponsor or CRO clinical research project/clinical operations management experience.</li>
<li>Experience contributing to or managing new business proposals strongly preferred. </li>
<li>Demonstrated ability to successfully execute all aspects of sponsor/CRO clinical trial management, as well as the ability to mentor and oversee the activities of other COMs.</li>
<li>Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.</li>
<li>Proficiency in Microsoft Office, particularly Outlook, Word and Excel.</li>
</ul>
<ul>
<li> Excellent communication and organizational skills.</li>
<li> Great attention to detail. </li>
</ul>
<ul>
<li>Exemplary skills leading and managing multi-disciplinary teams in a clinical research setting.</li>
<li>Ability to organize, instruct and supervise staff, while promoting group effort and achievement.</li>
<li>Ability to adapt quickly to new situations, manage conflicts and resolve problems effectively.</li>
</ul>
<ul>
<li> Willingness to travel 20-25% of the time.</li>
</ul>
Targeted Compensation: $95,000 - $115,000 annually

Deadline to Apply: June 1, 2024

Note: Viable applicants will be required to pass a background and education verification check.
About CPC:

CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more. 
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. <a href="http://www.cpccommunityhealth.org/" target="_blank">http://www.cpccommunityhealth.org/</a>
CPC offers:

<ul>
<li> Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)</li>
<li> Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)</li>
<li> 11 paid holidays</li>
<li>15 - 25 vacation days based on years of service</li>
<li>Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) </li>
<li> In-suite exercise and relaxation room</li>
<li> Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)</li>
<li> Flexible and remote work schedules</li>
</ul>
An Equal Opportunity Employer

CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at <a href="mailto:careers@cpcmed.org" target="_blank">careers@cpcmed.org</a>.

Clinical Trials Business Development Manager

<h3>Job Description</h3>
SiteBridge Research, Inc:
Founded in 2021, SiteBridge Research is an integrated research organization, focused on building a national network of small and community medical practices to deliver world-class industry sponsored clinical research studies on time and on budget, accelerating time to completing clinical trials, accelerating time to market and product adoption in communities that are often underrepresented and difficult to reach. The SiteBridge Network extends reach further into these communities to empower patients with some of the highest unmet needs to take part in clinical studies to improve inclusivity in clinical research and to improve overall health outcomes.
Job Description: The Clinical Research Project Manager is an experienced research professional who will provide support and manage projects with, and under the direction of, the Director of Clinical Research Coordinators &amp; Project Managers for multiple ongoing studies within our site network. This role requires in-depth industry understanding, knowledge, experience, and flexibility to make informed and effective decisions independently. The Clinical Research Project Manager will be responsible for identifying, developing, and gathering the necessary resources to complete clinical research projects and coordinate the project’s start-up, maintenance, and close-out activities. They will be required to work closely with the site staff to ensure the deliverables and timelines are met. In addition, and most importantly, this role represents SiteBridge Research’s mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will maintain the operational excellence required of clinical sites/staff involved in clinical studies and ensure ICH/GCP and SOP compliance. This role will report to the Director of Clinical Research Coordinators &amp; Project Managers and the Head of Clinical Operations. This position is remote with up to 40% travel for candidates with the prerequisite experience.
Responsibilities: 
<ul>
<li>Work closely under the direction of the Director of Clinical Research Coordinators &amp; Project Managers to coordinate project start-up, maintenance, and close-out activities (including but not limited to study start-up and close out, recruitment, and regulatory submissions) </li>
<li>Work collaboratively with the Clinical Operations leads, Project Managers, and site team to ensure project deliverables are completed.</li>
<li>As necessary, step in and fill site and study level needs (including but not limited to site set-up and CRC duties to meet SBR and sponsor needs)</li>
<li>Ensure ongoing communication to team members of the scope of work, timeline and project goals, technical information, and input from study teams throughout the project, including significant changes in resourcing, scope of work, and timelines</li>
<li>Evaluate and communicate metrics of all activity related to assigned projects </li>
<li>Consult with SiteBridge Leads to determine the best course of action for projects related to the site and trials </li>
<li>Effectively communicate with physicians, sponsors, stakeholders, and study staff as related to assigned projects</li>
<li>Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies </li>
<li>Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced, and objective manner</li>
<li>Prepare, participate in, and follow-up on audits/inspections as needed</li>
<li>Participate in required training and education programs.</li>
<li>Participate in meetings (i.e., Investigator Meetings, Site Trainings, Conferences) and seminars to update knowledge of clinical research and related issues as necessary </li>
<li>Other duties and support as assigned related to site and study operations</li>
<li>Travel is required (up to 40%) for projects related to site development and operations</li>
</ul>
Qualifications/Required Experience: 
<ul>
<li>Minimum Bachelor's degree; a combination of education and related technical/professional experience may be substituted for the degree requirement and will be considered on a case-by-case basis</li>
<li>Minimum of 4 years of clinical research or related experience; experience as CRC, CRA, or related is required</li>
<li>Minimum of 2 years of Project Management experience highly preferred </li>
<li>Bilingual, Spanish speaking candidates are encouraged to apply</li>
<li>Proven success managing and integrating multiple projects across an organization</li>
<li>Demonstrated knowledge of clinical trials project management and execution related to but not limited to start-up, regulatory submission, site feasibility, etc.</li>
<li>Excellent working knowledge of FDA &amp; ICH GCP regulations and guidelines is required </li>
<li>Experience with eSource, eRegulatory, and CTMS is required</li>
<li>Experience in study document preparation (CRF, eSource, logs, SOPs, etc.) is a plus</li>
<li>Strong preference for experience within multiple phase research and therapeutic areas</li>
<li>Experience with necessary clinical study and staff records related to clinical study activity which includes case report forms, drug dispensation records, etc. </li>
<li>Excellent communication skills, attention to detail, problem-solving, follow through, and organizational skills, with the ability to multi-task and work under/meet deadlines </li>
<li>Detail-oriented and meticulous in all aspects of work </li>
<li>Superior interpersonal, organization, and management skills</li>
<li>Capable of working independently with minimal supervision</li>
<li>Understanding of medical terminology as well as standard clinical procedures and protocols </li>
</ul>
Additional Qualifications: 
<ul>
<li>Strong project and time management skills </li>
<li>High level of collaboration; customer-oriented awareness and focus </li>
<li>Skilled with standard computer programs including the MS Office suite </li>
<li>Strong interpersonal and written and verbal communication skills </li>
</ul>
Additional Information:
SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills, and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

Clinical Research Project Manager

<h3>Job Description</h3>
Experic is an industry-leading contract development and manufacturing organization (CDMO) and clinical trial supply services company. Our vision is to deliver innovative and scalable solutions for every phase of a product's life cycle from clinical to commercial. We offer advanced pharmaceutical manufacturing, packaging, and labeling technologies that can accommodate a variety of dosing and packaging formats. We take pride in our precision capabilities, state-of-the-art filling equipment, advanced technologies, and Class A regulatory compliant cGMP facilities. Our main goal is to provide our clients personalized attention and ensure the smooth and successful completion of their pharmaceutical development programs. 

We aspire to develop a team culture based on trust, integrity, ethical behavior, and compliance, with a relentless focus on delivering high quality results. If you value a collaborative work environment and are energized by the opportunity to truly make a difference, come and Experience the Experic difference. We believe in fostering a fair and respectful work environment that encourages open communication and continuous improvement. At Experic, you can experience a fulfilling career, do meaningful work, and grow professionally and personally. A successful candidate will bring their unique thinking, expertise, and approach while sharing our core values.
Job Summary:
The successful candidate will be responsible for establishing, implementing, and reporting on a sales strategy to achieve revenue goals for their assigned region. The candidate is responsible for the execution of the full sales life cycle from prospect identification through contract execution.

Essential duties and responsibilities include the following. Other duties may be assigned.
<ul>
<li>Achieve established sales and utilization goals in the assigned territory.</li>
<li>Responsible for identifying, qualifying, managing and growing client accounts.</li>
<li>Increasing client's knowledge and awareness of Experic's services and capabilities.</li>
<li>Pre-planning sales calls and maintaining efficient time management skills to ensure maximum client and prospect contact.</li>
<li>Provide timely and efficient customer service to your clients and prospects in your pipeline.</li>
<li>Completing administrative responsibilities including periodic sales plans, monthly expense reports, up-to-date account profiles and customer database.</li>
<li>Manage day-to-day sales administration activities in a detailed and timely manner capturing and maintaining all business development activities in our Customer Relationship Management System (CRM).</li>
<li>Collaborate with the business development team and company subject matter experts in the execution of these duties.</li>
</ul>

Additional Position Requirements:
<ul>
<li>Maintaining updated knowledge of the industry and competitive services.</li>
<li>Developing and maintaining supportive, productive and effective relationships at all levels within the organization.</li>
<li>Participating in industry-related trade shows/meetings.</li>
<li>Maintain consistent communication with appropriate leadership and sales teams.</li>
<li>Demonstrate a strong work ethic and represent the Company with high integrity, ethics, honesty, loyalty, and professionalism at all times.</li>
<li>Carries out duties in compliance with all federal and state regulations and guidelines including FDA and other regulatory agencies.</li>
<li>Complies with all company and site policies and procedures.</li>
<li>Remains current in profession and industry trends.</li>
<li>Makes a positive contribution as demonstrated by: making suggestions for improvement and learning new skills, procedures and processes.</li>
</ul>

Education/Experience:
Bachelor's Degree required plus a minimum of five (5) years of demonstrated successful business development experience selling contract manufacturing services in the pharmaceutical and biotech industries.
Competencies:
<ul>
<li>Demonstrated experience developing a client base and network in the contract pharmaceutical manufacturing market.</li>
<li>Experience with sales and business development in the pharmaceutical industry.</li>
<li>Familiar with the entire sales life cycle for contract services.</li>
<li>Demonstrated ability to remain effective and productive working remotely out of a home office.</li>
<li>Successfully completes regulatory and job training requirements.</li>
<li>Experience using a CRM tool to support execution of business development activities.</li>
<li>Work and be proficient with e-mail systems.</li>
<li>Experience using MS Office applications including Word, Excel, PowerPoint and Outlook.</li>
<li>Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.</li>
<li>Ability to work with others in a team environment.</li>
</ul>
Working Conditions:
Standard office environment with minimal 20% travel
Physical Demands:
Office Environment (standing and sitting) requiring minimal physical exertion.
Experic maintains a highly competitive, performance-based compensation programs. Employees may be eligible to participate in Company employee benefit programs such as health insurance, 401k plan, disability plan, vacation pay/sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. 
Experic is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

CDMO Business Development Manager - Remote - San Francisco, CA

<h3>Job Description</h3>
Company introduction:
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments. 
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
Job overview:
The Clinical Project Coordinator will be responsible for supporting the planning, coordination, and implementation of clinical research projects. They will also monitor and present project updates to relevant stakeholders, clients, or project team members.
Location: Remote on the West Coast, USA or hybrid in our San Francisco, USA office. 
Reports to: The Clinical Project Manager will report to the Manager, Clinical Project Coordination.
Roles and responsibilities
Responsibilities include (but are not limited to): 
<ul>
<li>Supports members of the Clinical Operations and Therapist Training team in the planning and conduct of cross-functional clinical research projects</li>
<li>Provides day-to-day operational support for all Compass Pathways clinical trials</li>
<li>Liaises with clinical trial sites to develop and implement creative solutions to address recruitment barriers/challenges</li>
<li>Works closely with external collaborators, including CROs and clinical vendors, to provide robust support to clinical trial sites</li>
<li>Monitors project deliverables and updates relevant stakeholders or team members on project progress, where appropriate</li>
</ul>
Profile:
<ul>
<li>Bachelor's Degree or equivalent experience</li>
<li>Experience in a clinical research setting, ICH and GCP</li>
<li>Excellent interpersonal, verbal and, written communication skills</li>
<li>Ability to manage multiple projects and tight deadlines</li>
<li>Working knowledge of the key elements of clinical trial operations</li>
<li>Experience in Pharma/Biotech, CRO and/or academic research is essential</li>
<li>An inquiring mind and great enthusiasm to work in an exciting and fast-moving environment</li>
<li>Aligned to our company mission and values of Compassionate, Bold, Rigorous and Inclusive</li>
</ul>
【For NYC】Compensation Description (annually):
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.
【Base salary per annum】:$75,000—$95,000 USD
Benefits &amp; Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass". 
Equal opportunities: 
UK applicants
We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.
US applicants
Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.

Clinical Project Coordinator

<h3>Job Description</h3>
Salary: $42.55 - $65.87
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Clinical Research Coordinator will be assigned to pharmaceutical studies, device clinical trials, and/or investigator-initiated research projects. This position works under the supervision of Principal Investigator(s) and Director, Clinical Research Operations whose research activities are conducted under good clinical practice (GCP) guidelines. Work hours will need to be flexible to meet individual project needs. Evening, weekend, and overnight hours may be required. Attendance at departmental and weekly general staff meetings is expected. This is not a fully remote position and while some remote work may be permitted at times, consistent in-person attendance is required.
This position will fulfill the following specific functions:
<ol>
<li>Responsible for the integrity and overall quality of assigned clinical research trials</li>
<li>Responsible for organizing and leading assigned studies</li>
<li>Communicates with the sponsor’s site monitors, Clinical Research Associates (CRAs), and local and/or central Institutional Review Boards (IRBs)</li>
<li>Prepares, schedules, and leads and/or participates in study visits with monitors, sponsors, and auditors</li>
<li>Trains Clinical Research Assistants and Ambassadors on studies, policies, procedures, and other topics as appropriate</li>
<li>Follows GCP regulations, state and local laws, and study protocols</li>
<li>Participates in the Informed Consent process, potentially including drafting, amending, and conducting Informed Consent visits with study subjects</li>
<li>Reviews protocols to ensure each study fits with the SDRI mission statement and that we can actively recruit the required subject population and conduct the study successfully</li>
<li>Create and maintain source documents</li>
<li>Completes Case Report Forms (CRFs) for assigned studies and enters electronic data as required by the study
<ol>
<li>CRFs will be completed and up-to-date prior to site monitor visits</li>
<li>Changes or corrections noted by the monitors will be completed before the next scheduled monitor visit date or as specified by the sponsor’s deadline</li>
</ol>
</li>
<li>Completes and submits Adverse Event (AE) forms per protocol and regulatory guidelines and Serious Adverse Events (SAE) forms to the sponsor and the IRB within 24 hours of SAE occurrence</li>
<li>Supervisees recruitment process for assigned studies, screens potential subjects, and conducts subject visits</li>
<li>Establishes and maintains relationships with study subjects and participates in subject education regarding the clinical trial process, and provides specific trial information to each subject/volunteer </li>
<li>Completes regulatory documents for assigned studies, including submission for IRB initial approval and applicable renewals</li>
<li>Attends Investigator Meetings as assigned</li>
<li>Maintains drug and device accountability and dispensing logs for assigned studies</li>
<li>Clinical duties include, but are not limited to:
<ol>
<li>Completion of comprehensive medical history for study subjects</li>
<li>Measure vital signs, weight, and height of study subjects per protocol and reports any abnormal results to the Principal Investigator or sub-Investigator</li>
<li>Phlebotomy and blood sample processing according to universal bloodborne pathogen precautions</li>
<li>Recording 12-lead ECGs per protocol</li>
<li>Providing ongoing patient education</li>
<li>Ordering outside laboratory tests and/or procedures on an as-needed basis</li>
</ol>
</li>
<li>Laboratory duties include:
<ol>
<li>Centrifugation of blood samples</li>
<li>Processing and packaging of body fluid samples (including but not limited to blood, urine, and saliva)</li>
<li>Proper sample storage</li>
<li>Proper shipment of samples, including contacting the appropriate courier</li>
</ol>
</li>
<li>Maintains cleanliness and order in all of the designated areas during studies. Complies with Safety Committee policies and recommendations</li>
<li>Assists with medical writing as appropriate and assigned, including protocols, scientific papers, and grant writing</li>
<li>Supports Clinical Trial Business Manager in staffing and scheduling for studies as appropriate</li>
<li>Assists Clinical Trial Business Manager as needed with study contracts and budgets</li>
<li>Other duties as assigned by superiors</li>
</ol>

SUPERVISORY RESPONSIBILITIES

Incumbent will supervise Clinical Research Ambassadors and Clinical Research Associates I-II.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Training will be provided where necessary and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
<ul>
<li>Basic knowledge of accepted clinical research practices, including universal precautions, human subjects research protocols and HIPAA requirements</li>
<li>Knowledge of drug development process, ICH guidelines and FDA CFRs</li>
<li>Ability to lead pivotal studies independently</li>
<li>Ability to handle 3 or more studies simultaneously and effectively delegate tasks to Clinical Research Assistants</li>
<li>Ability to work independently and with careful attention to detail as well as in collaboration with other staff members </li>
<li>Basic knowledge of office practices and office equipment</li>
<li>Basic knowledge of computer systems for word processing, electronic mail, data entry, and electronic data transfer</li>
<li>Basic typing skills</li>
<li>Excellent multi-tasking, prioritization, communication, and organizational skills and ability to work under stress</li>
<li>Ability to transfer and record data accurately, in the required format, and in a timely manner</li>
<li>Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.</li>
<li>Interpersonal skills, public speaking, and report writing abilities</li>
<li>Ability to understand and carry out instructions in written, oral, or diagram form</li>
<li>Proven ability to deal with problems with several variables and ability to prioritize tasks and activities in a manner consistent with direction from supervisor</li>
<li>Ability to think and reason critically</li>
<li>Strong managerial skills and ability to support, train, and supervise subordinates as well as effectively manage and troubleshoot issues as appropriate</li>
</ul>

EDUCATION AND EXPERIENCE

<ul>
<li> Experience working in a medical setting</li>
<li> At least three years of experience working in clinical research</li>
<li> High school diploma and Bachelor’s degree or equivalent experience</li>
<li> Scientific or nursing education desirable</li>
<li> Phlebotomy skills desired</li>
<li> ACRP CCRC certification highly desirable</li>
</ul>

LANGUAGE SKILLS

The ability to read, write and speak English clearly is required. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency highly desired.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The incumbent is regularly required to sit, talk, hear, and climb stairs. The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files. The incumbent is required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10-20 pounds. Specific vision abilities required by this job include close vision.
This position requires manual dexterity, skill level and adequate vision to record data onto data sheets and adequate hearing and verbal communication skills to converse with study subjects.  Standing for extended periods of time as well as light lifting is necessary. 
The incumbent must be in sufficient overall health to report for work consistently and reliably and work through a standard day with appropriate breaks.   
WORK ENVIRONMENT
The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting.
This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.  
This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed.

Clinical Research Coordinator II

<h3>Job Description</h3>
Manager, BioPharma Business Development is responsible for growing Predicine’s BioPharma business to be a partner of choice. This key position will be part of a growing team to shape the oncology precision medicine industry with BioPharma partners to enable liquid biopsy testing in clinical trials.
What you will get to do:
<ul>
<li>Support BioPharma customer success by integrating Predicine’s liquid biopsy solutions into clinical trial design and analysis.</li>
<li>Learn about Predicine’s cutting edge technology, and how it can be used to improve patient outcomes via clinical trials.</li>
<li>Engage with academic institutions and Key Opinion Leaders (KOL’s) to support data-generation for BioPharma customers.</li>
<li>Work with business development team members to ensure customers receive quality and valuable engagement with Predicine.</li>
<li>Create clear and concise sales presentations addressing customer and industry gaps in oncology liquid biopsy testing.</li>
<li>Establish, maintain, and grow relationships with key decision-makers within assigned accounts.</li>
<li>Navigate customer accounts by learning processes, corporate strategy, and identifying key stakeholders for effective engagement.</li>
<li>Conduct thorough customer pipeline analysis by identifying key pieces of information and using available tools to identify potential new business opportunities.</li>
<li>Develop new or unique approaches to address new business opportunities and develop action plans to pursue them.</li>
<li>Support partnering activities through trust-based relationships and reinforcing Predicine as liquid biopsy partner of choice. </li>
<li>Attend conferences, roadshows, and onsite customer visits to showcase Predicine capabilities.</li>
<li>Assess information relevant to sales, identify key issues, and develop solutions through sales environment adjustments.</li>
<li>Work cross-functionally with marketing, project management, R&amp;D, legal, and translational teams to provide top-tier end-to-end customer experience.</li>
<li>Monitor and adhere to timelines for company goals and adjust based on changing customer or business needs.</li>
</ul>
Qualifications: 
<ul>
<li>Bachelor’s Degree, advanced degree preferred</li>
<li>3+ years experience in a business development, consulting, or sales role within molecular diagnostics, pharmaceuticals, healthcare, research, or similar industry environment</li>
<li>History of proven results and successful sales performance</li>
<li>Oncology and/or molecular diagnostic experience</li>
<li>Proficient with MS Office (e.g., Word, Excel, and PowerPoint)</li>
</ul>
Knowledge, Skills, and Abilities:
<ul>
<li>Thrive in a Fast-Paced environment.</li>
<li>Ability to travel up to 40%.</li>
<li>Proficient knowledge of the oncology clinical and diagnostic landscape.</li>
<li>Willingness to learn, grow, and go above and beyond within an organization.</li>
<li>Eager to regularly conduct cold call reach out to prospective customers highlighting new data and information.</li>
<li>Excellent communicator with individuals and groups alike.</li>
<li>Proactively create solutions to emerging or ongoing issues.</li>
<li>Familiarity with different sales techniques and pipeline management.</li>
<li>Demonstrated track record of success selling oncology-based tests or services.</li>
<li>Adaptable, can-do attitude to support individual, team, and organization success.</li>
<li>Demonstrated strong attention to detail and organizational skills.</li>
<li>Discernment to execute on value-adding tasks while addressing ongoing urgent needs.</li>
<li>Work well under pressure while maintaining a professional demeanor. </li>
<li>Ability to collaborate with peers in a fast-paced and cross-functional team environment.</li>
</ul>
Our Opportunity
 Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology. 
What we offer
 Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, for eligible employees and their dependents. Additionally. Other benefits include stock allocation and 401k benefits, and an employee referral program.
 We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
 All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

Manager, BioPharma Business Development (EAST COAST/ REMOTE)

<h3>Job Description</h3>
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 
Summary of Role
Manage the Investigator Sponsored Trial program across the Lantheus Medical Imaging portfolio for all Lantheus assets, including all processes related to multiple functional areas.
Essential Functions
<ul>
<li>Independently manages tracks and monitors the Global Investigator Sponsored Trial program across all Lantheus assets and ensure that compliance with SOPs is documented for all processes within the assigned portfolio.</li>
<li>Interfaces with physicians and scientists for study conduct and regulatory compliance for investigator sponsored trials in a global environment. This includes all facets of the process across multiple functional areas from concept development through to publication and dissemination of findings.</li>
<li>Ensures IST study files meet GCP requirements, regulatory requirements (including drug accountability) and accurately reflect the content and status of all IST’s.</li>
<li>Ensures the preparation of new IST applications for review by Research Review Committee (RRC) for all pre-clinical and clinical IST protocols.</li>
<li>Interact as needed with investigators, applicants and site staff as needed to effectively review and implement IST proposals.</li>
<li>Interface with Pharmacovigilance function, external business partners and distributors to promote strategic alignment &amp; safety requirements for marketed products involved in the IST program.</li>
<li>Support the IST agreement (contract) process for all IST’s, in collaboration with medical, legal, and regulatory functions.</li>
<li>Support activities to drive adherence to timelines, program objectives and monitoring plans. Accountable for accuracy and timeliness of information in all databases and tracking systems.</li>
<li>Integrates a range of data and input from multiple sources and collaborate effectively across multidisciplinary work teams required to review, assess and accurately document IST program content.</li>
<li>Provides updates to all relevant departments (e.g., R&amp;D, marketing, customer service, business development) as needed.</li>
<li>Ensures adequate understanding of IST research content and requirements to be able to fluently interact with Lantheus staff, external investigators, and site staff.</li>
<li>Develops and maintains knowledge of regulatory and operational aspects of the management of clinical trials in all countries where ISTs are located.</li>
<li>Ensures accurate reporting on progress, milestone achievement and issues to upper management. Recognizes and escalates to appropriate personnel significant issues relating to compliance, timelines or other issues that jeopardize business objectives.</li>
<li>Actively demonstrates and promotes the Lantheus values of accountability, quality, efficiency, customer service, collaboration and safety.</li>
<li>Manages multiple competing responsibilities and adapt to continually shifting priorities and day to day demands.</li>
</ul>
Typical Minimum Skills and Experience and Education 
<ul>
<li>Bachelor’s degree or equivalent in a scientific or health related field required. Advanced healthcare professional degree (e.g., PharmD, PhD, DO or MD or equivalent strongly preferred). </li>
<li>Knowledge of medical imaging field and diagnostics agents preferred. Project management training or one or more years of experience. Working knowledge of current ethical, GCP and regulatory guidelines.</li>
<li>Minimum 3 years’ experience in Investigator Sponsored Trials and/or Clinical Trial Operations, in post marketed products.</li>
<li>Typically requires 2 + years of related professional industry experience.</li>
</ul>
Other Requirements
<ul>
<li>Knowledge/training in prostate cancer therapy and imaging agents an advantage.</li>
<li>Demonstrated ability to efficiently assimilate diverse and complex medical and scientific data from sponsored or independent non-clinical and clinical studies and articulate summary information in verbal and written form.</li>
<li>Occasional travel based on educational or business purposes</li>
</ul>
Core Values:
The ideal candidate will embody Lantheus core values:
<ul>
<li>Let people be their best</li>
<li>Respect one another and act as one</li>
<li>Learn, adapt, and win</li>
<li>Know someone’s health is in our hands</li>
<li>Own the solution and make it happen</li>
</ul>
#LI-REMOTE

Global Medical Affairs Research Manager (Remote)

<h3>Job Description</h3>
Salary: 
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

POSITION SUMMARY
Structure is seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. This role is responsible for forecasting Investigational Product (IP) supply requirements, managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Collaborates and interacts internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, CMC and externally with Clinical Service Providers (e.g., CROs, IP Drug Depot). This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department. #LIHybrid

ESSENTIAL DUTIES AND RESPONSIBILITIES
· Manage all aspects of IP supply planning, logistics, and sourcing of comparator and ancillary supplies to ensure alignment with study plans, timelines, budget, and overall clinical development plan.
· Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
· Manages relationships with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
· Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
· Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
· Manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, IRT start-up through study closure, label generation and approval, packaging and labeling operations, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
· Manages the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
· Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists
REQUIREMENTS
Education
· BA/BS required, preferably in a scientific discipline preferred. Other BA/BS degree with clinical supply experience will be considered.
Experience
· 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management.
· Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, global studies required
· Experience in IP logistics in APAC (e.g., IP manufacturing and import from Asia to US) preferred
· Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
· Experience in operations and systems, including replenishment planning, capacity analysis, manufacturing, and distribution in either clinical or commercial environment
· Strong understanding and proven experience in IRT and other drug supply management systems, as well as experience in overseeing CROs and CDMOs
· Experience in operations and systems, including replenishment planning capacity analysis, manufacturing, and distribution in a clinical or manufacturing environment
· Knowledge of import/export policies

Core competencies and skills
· The ability to prioritize and handle multiple activities on a daily basis yet flexible and responsive to frequently shifting priorities
· Demonstrated ability to integrate into a remote team environment (US, APAC) with a positive attitude
· Action-oriented with excellent problem-solving skills
· Strong sense of ethics and honesty
· Other qualitative requirements:
o Organizational skills
o Result-driven
o Strategic agility
o Resilience and flexibility dealing with ambiguity

Travel
· Up to 20%



The target salary range for this full-time role is $164,000- $196,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

Sr. Manager Clinical Supplies Planning and Logistics

<h3>Job Description</h3>
Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. Position: Coordinator, Clinical Operations, Logistics Location: Remote Duration: 12 Months Job Type: Contract Work Type: Remote Job Description
<ul>
<li>The Clinical Logistics Coordinator is responsible for investigational product cell journey logistics, chain of custody, and chain of identity. </li>
<li>In so doing, this role collaborates with several cross functional stakeholders, including clinical trial personnel, Clinical Operations, Data Management, Clinical Development, Medical Affairs, Regulatory Affairs, Technical Operations, Manufacturing, MSAT, and Quality. </li>
<li>This role is a part of the study management team and reports to the Clinical Operations Logistics Manager. </li>
</ul>
Responsibilities (include but are not limited to):
<ul>
<li>Arranges product cell journey logistics: all transport legs, customs, courier, and broker interactions </li>
<li>Communicates study enrolment requirements pertaining to the cell journey </li>
<li>Contributing member of Clinical Trial study teams </li>
<li>Drives the cell journey for assigned primary and backup studies </li>
<li>Engages Contract Research Organizations to facilitate the cell journey </li>
<li>Interacts with investigational site medical personnel </li>
<li>Maintains product chain of identity and chain of custody </li>
<li>Participates in 24/7 on-call response program </li>
<li>Provides training at study trial meetings as needed </li>
<li>Tracks and prepares cell journey information utilizing databases, spreadsheets, and other tools </li>
<li>Utilizes vendor/supplier systems to place relevant orders </li>
<li>Works cross-functionally with Technical Operations, Manufacturing, Quality and other depts to facilitate the clinical product cell journey </li>
<li>Arranges meetings, agendas, and minutes </li>
<li>Travel as needed </li>
<li>Other duties as assigned </li>
</ul>
Basic Qualifications:
<ul>
<li>4+ years of relevant clinical or logistics experience </li>
<li>2+ years of relevant clinical or logistics experience with a BS/BA </li>
<li>0 years of relevant clinical or logistics experience with a MS/MA </li>
</ul>
Preferred Qualifications:
<ul>
<li>Detail oriented </li>
<li>Able to work independently and as part of a team </li>
<li>Excellent verbal and written communication </li>
<li>Experience with Agile change control management a plus </li>
<li>Experience with courier services </li>
<li>Experience with CRM systems: Salesforce, Oracle, SAP a plus </li>
<li>Experience with ERP systems: Oracle, SAP a plus </li>
<li>Familiar with domestic and international logistics/transport of biologic material (IATA, ICAO, ADR, DOT, WHO). </li>
<li>Knowledge of biological tissue transportation and logistics </li>
</ul>
Required Years of Experience:
<ul>
<li>2-5 years </li>
</ul>
Top 3 Required Skill Sets:
<ul>
<li>Logistics background, clinical trial experience, ability to be on call when needed </li>
</ul>
Top 3 Nice to Have Skill Sets:
<ul>
<li>Comparator drug sourcing, demand planning, IT experience </li>
</ul>
Unique Selling Point of this role:
<ul>
<li>Ability to work with our clinical trial sites and manage patients cell journey for treatment. </li>
</ul>
Required Degree or Certification?
<ul>
<li> College degree preferred </li>
</ul>
Any Disqualifiers?
<ul>
<li>None at this time </li>
</ul>
TekWissen Group is an equal opportunity employer supporting workforce diversity.

Coordinator, Clinical Operations, Logistics

<h3>Job Description</h3>
POSITION TITLE: Senior Clinical Research Associate
DEPARTMENT: Monitoring
Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.
The Role:
Ora's Senior Clinical Research Associate (Sr. CRA) develops strong clinical site relationships and are accountable for performance and compliance with assigned protocols at our sites. Our Sr. CRA's will work with the oversight of the Lead CRA and Line Manager. As a Sr. CRA, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross-functionally with Ora's Quality Assurance and Regulatory teams, and developing relationships with sponsors and sites through all phases of the trial. To be successful, you will need to obtain a deep understanding of various study protocols and be prepared to provide input on site selection and validation activities. After completing all required training, Ora Sr. CRA's will support the site contact and site managers, and act as the primary site contact and site manager throughout all phases of a clinical research study, taking responsibility for allocated sites.
What You'll Do:
<ul>
<li>Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.</li>
<li>Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws &amp; Regulations, Protocol, Site Monitoring Plan and associated documents.</li>
<li>Gain in-depth understanding of the study protocol and related procedures.</li>
<li>Coordinate &amp; manage various tasks in collaboration with other internal roles to achieve Site Readiness.</li>
<li>Participate &amp; provide input on site selection and validation activities.</li>
<li>Perform remote and on-site monitoring &amp; oversight activities using various tools to ensure:</li>
<li>Data generated at site are complete, accurate and unbiased</li>
<li>Subjects' right, safety and well-being are protected</li>
<li>Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit &amp; non-visit contact reports appropriately in a timely manner.</li>
<li>Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.</li>
<li>Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.</li>
<li>Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.</li>
<li>Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.</li>
<li>Supports audit/inspection activities as needed.</li>
<li>Travel Requirements up to 75%.</li>
<li>Adhere to all aspects of Ora's quality system.</li>
<li>Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity &amp; business ethics and regulatory requirements.</li>
<li>Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.</li>
<li>Responsibilities may differ from the above based on the specific needs of the business</li>
</ul>
What We Look For: 
<ul>
<li>Experience needed for the Role: 
<ul>
<li>Bachelor's degree with 3 years' experience as a Clinical Research Associate or equivalent combination of education, training and experience. Years of experience may be considered in lieu of education.</li>
</ul>
</li>
<li>Additional Skills &amp; Attributes:
<ul>
<li>Ophthalmic experience is strongly preferred.</li>
<li>Capacity to routinely assess protocol and GCP compliance.</li>
<li>Ability to understand how to properly assess an investigative site's capabilities to conduct clinical research.</li>
<li>Demonstrated ability to verify source data to reported data.</li>
<li>Ability to monitor and report on the progress of the trial from start-up to completion.</li>
<li>Knowledge of how to select and qualify an investigative site</li>
<li>Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits.</li>
<li>Advanced knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).</li>
<li>Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol.</li>
<li>Proficiency with Excel, CTMS, and EDC.</li>
<li>Multilingual communication is a plus.</li>
</ul>
</li>
</ul>
Competencies and Personal Traits:

<ul>
<li>What We Do:
<ul>
<li>Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work.</li>
</ul>
</li>
<li>How We Do It:
<ul>
<li>IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.</li>
<li>Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.</li>
</ul>
</li>
<li>Why We Do It:
<ul>
<li>Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.</li>
</ul>
</li>
</ul>

What We Offer:
<ul>
<li>Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.</li>
<li>Flexible PTO &amp; Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays. </li>
<li>Financial: Competitive salaries along with a 401K plan through Fidelity with company match. </li>
<li>Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave. </li>
<li>Company Paid Life &amp; Disability Insurance: Offering peace of mind to help you and your family feel secure. </li>
<li>Remote &amp; Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases. </li>
<li>Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family. </li>
<li>Career Development Opportunities:Continued opportunities to grow and develop your career journey. </li>
<li>Global Team: Opportunities to work with colleagues across the globe. </li>
<li>Impact: A chance to research new ophthalmic therapies that will impact patients across the globe. </li>
</ul>
Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. 
Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. 
We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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60 Remote Clinical Trial Manager Jobs