Job Description
Position Title: Sr. Clinical Research Associate, Clinical Affairs (Remote or Corporate Office)
Position Overview: The Sr. Clinical Research Associate (CRA), Clinical Affairs supports the planning, execution, and close-out of clinical trials by providing centralized monitoring and operational support. This role will work closely with Clinical Project Managers, CROs, investigators and site staff, to ensure studies are conducted in compliance with protocol, ICH-GCP, SOPs, and applicable regulatory requirements.
The Sr. CRA is responsible for providing centralized clinical trial oversight and operational support to ensure the successful execution of clinical studies. This role supports study start-up, interim, and close-out activities through on-site and remote monitoring, documentation management, site support, and cross-functional coordination.
Essential Duties and Responsibilities: - Support clinical study start-up, interim, and close-out activities, maintaining alignment with protocol requirements, internal procedures, applicable regulations, and good clinical practices.
- Perform centralized, on-site, and remote monitoring activities, including data review, trend analysis and risk escalation.
- Review clinical data for completeness, consistency, and protocol compliance.
- Support query management and collaboration with Data Management.
- Prepare study status reports and dashboards.
- Act as a primary point of contact for assigned investigational sites for day-to-day operational questions
- Support site onboarding, training, and ongoing communication.
- Collect and maintain accurate and timely trial documentation in clinical systems (eTMF, CTMS, EDC).
- Monitor and provide regular updates on study timelines, budgets, and risk mitigation activities.
- Ensure trial activities comply with all legal and regulatory requirements including but not limited to ICH-GCP, HIPAA compliance, Institutional Review Boards/ Ethics Committees, etc. and company SOPs.
- Support regulatory submissions, amendments, and safety reporting processes, as applicable.
- Assist with audit and inspection readiness activities, identifying quality issues and support corrective activities.
- Ensure proper supervision and training for all clinical study staff, CRO resources and field monitors.
- Contribute to process improvement initiatives within Clinical Affairs.
- Collaborate cross-functionally with regulatory, legal, compliance and other departments as required.
- Attend and participate in regional, national, and international scientific and clinical meetings, as applicable.
- Develop and foster relationships with key clinical customers (e.g., physicians, nurses, administrators, research staff).
Education and Experience: - Bachelor's degree in Life Sciences or related field
- Advanced degree or clinical research certification preferred
Required Knowledge, Skills and Abilities: - Minimum of 4 years of experience in clinical research with at least 2 of those years with demonstrated on-site monitoring experience.
- Experience in Medical Devices is preferred, with prior experience in US IDE clinical studies is highly desired.
- Solid understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP, ISO 14155, CFR 820, EU MDR, UKCA); ability to work within the constraints of a regulated industry while achieving objectives.
- Excellent interpersonal relationship skills including collaborating, negotiating, and influencing to drive achievement of objectives.
- Strong communication (oral and written) skills including publications, regulatory documents, and presentations; ability to communicate in small and large settings and with all organizational levels, regulatory agencies, and physicians.
- High attention to detail and ability to manage multiple priorities.
- Ability to thrive in a fast paced, dynamic, and constantly changing work environment with competing priorities.
- "Hands-on", "roll-up-the-sleeves" leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team.
- Proficient with MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), and EDC (electronic data capture).
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.
Must be able to:
- Ability to carry and lift product inventory of up to 10 lbs.
- Must have demonstrated ability to multitask in high pressure, changing conditions.
Working Conditions This position works in a home office, hospital, HCP office, home office or clinical environment. The noise level in the work environment is quiet to moderate.
Primary Location and Travel: - Ability to travel up to 50%
We anticipate that on an ongoing basis this role will be a office-based position although the incumbent will need to participate in face to face Corporate meetings as needed.
Disclaimers: This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.
TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.
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Job Tags
Full time, Interim role, Local area, Work from home, Home office