Sr. Clinical Trial Assistant - Bay Area
Structure Therapeutics
16 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
- Acts as central contact for the designated clinical study team, supporting planning, implementation, and completion of clinical studies (outsourced or in-house) via interaction with sites, vendors, and team members.
Job Responsibilities
- Obtain, review, process, and track study documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
- Set up, maintain, and close Trial Master File (TMF/eTMF); perform QC as assigned and resolve discrepancies.
- Maintain/update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare agendas and take comprehensive minutes for internal/external meetings.
- Support study-level tracking (monitor visit tracking, sample tracking, supplies, etc.).
- Assist with investigator meeting materials, monitor workshops, and study manual.
- Coordinate with team members/Regulatory Affairs to ensure timely document completion and handover.
- Interface with cross-functional groups for timely exchange of information/materials.
- Assist with data reconciliation and review of clinical data in the database (as assigned).
- Update/manage public clinical trial listings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance policies (obtain/review, track/renew certificates).
- Prioritize work activities to meet deadlines; may take on additional study needs.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 2+ years of biotechnology/pharmaceutical/clinical trial management experience (global experience a plus).
- Familiarity with eTMF/document filing; excellent communication/interpersonal skills.
- Strong organization, attention to detail; ability to manage multiple priorities.
- Proficient in Microsoft Word/Excel.
Travel
- Up to 20%.
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown); annual performance incentive bonus; new hire equity and performance-based equity.
- Acts as central contact for the designated clinical study team, supporting planning, implementation, and completion of clinical studies (outsourced or in-house) via interaction with sites, vendors, and team members.
Job Responsibilities
- Obtain, review, process, and track study documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
- Set up, maintain, and close Trial Master File (TMF/eTMF); perform QC as assigned and resolve discrepancies.
- Maintain/update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare agendas and take comprehensive minutes for internal/external meetings.
- Support study-level tracking (monitor visit tracking, sample tracking, supplies, etc.).
- Assist with investigator meeting materials, monitor workshops, and study manual.
- Coordinate with team members/Regulatory Affairs to ensure timely document completion and handover.
- Interface with cross-functional groups for timely exchange of information/materials.
- Assist with data reconciliation and review of clinical data in the database (as assigned).
- Update/manage public clinical trial listings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance policies (obtain/review, track/renew certificates).
- Prioritize work activities to meet deadlines; may take on additional study needs.
Qualifications
- Bachelor’s degree in a relevant scientific discipline.
- 2+ years of biotechnology/pharmaceutical/clinical trial management experience (global experience a plus).
- Familiarity with eTMF/document filing; excellent communication/interpersonal skills.
- Strong organization, attention to detail; ability to manage multiple priorities.
- Proficient in Microsoft Word/Excel.
Travel
- Up to 20%.
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays (including winter shutdown); annual performance incentive bonus; new hire equity and performance-based equity.