Senior Clinical Research Associate

A Senior Clinical Research Associate will work closely with clinical operations and the cross-functional study execution team to implement all aspects of clinical trials to support multiple clinical programs. The position will liaise with clinical sites, central labs, biomarker labs and internal stakeholders to ensure successful execution across Adicet’s clinical programs.

Key responsibilities include:

• Collect, track and conduct initial review for completeness of site regulatory documents for TMF filing
• Maintain oversight of the progress of assigned clinical trials by updating multiple study tracking documents: subject tracking, essential document tracking, and sample collection/management and investigational product tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
• Assist in tracking legal documents such as site and vendor CDAs, contracts and Work Orders
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
• Assist with the development of site tools and clinical trial start-up activities
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study plans/manuals, study communications and presentations
• Assist in tracking of trial IP and development of Pharmacy Manuals
• Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
• Assist with tracking of clinical trial progress including status update reports, as requested
• Assist with the organization, management and conduct of internal team meetings, and other trial-specific meetings, including minute taking and action item log tracking
• Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
• May assist CTM in review of monitoring reports, tracking and follow-up of monitoring visit reports and unresolved issues
• Other duties as may be assigned

Qualifications:

• BS with 2 years’ experience in pharmaceutical or biotech industry
• Experience managing central labs, biomarker labs and operations
• Solid understanding of cGMPs, clinical operations, and drug development processes
• Detailed oriented with ability to work in a fast-changing environment
• Strong analytical, problem solving, and communication skills.
• Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.