TELA Bio
Malvern, Pennsylvania, United States
(on-site)
Posted
8 days ago
Job Type
Full-Time
Salary
$80,000.00 - $105,000.00
Salary - Type
Yearly Salary
Job Function
Other
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:
Education and Experience:- 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).
- Bachelor's degree in Life Sciences or related field
- Advanced degree or clinical research certification preferred
- 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).
- Ability to carry and lift product inventory of up to 10 lbs.
- Must have demonstrated ability to multitask in high pressure, changing conditions.
- Ability to travel up to 50%
PI282502890
Job ID: 82623594
