Sr. Clinical Trial Assistant - Bay Area (MP)
Structure Therapeutics
June 30, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
- The Senior Clinical Trial Associate (SCTA) is the central contact for the designated clinical study team, supporting planning, implementation, and completion of clinical studies (outsourced or in-house) via interaction with investigative 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 out the Trial Master File (TMF/eTMF); perform QC as assigned and resolve discrepancies.
- Maintain and update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare agendas and take comprehensive minutes for internal/external meetings.
- Track study activities as assigned (monitor visit tracking, sample tracking, study supplies).
- Assist with materials for investigator meetings, monitor workshops, and the study manual.
- Coordinate with Regulatory Affairs to ensure documents are completed accurately and handed over within requested timeframes ahead of submission deadlines.
- Coordinate cross-functional information/material exchange as assigned.
- Assist with data reconciliation.
- Participate in review of clinical data in the clinical database, data listings, and reports as assigned.
- Update and maintain public clinical trial listings/postings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance (obtain/review policies, track renewals/expiring certificates).
- Prioritize and plan work to meet deadlines; may take on additional study-related responsibilities.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 2+ years in biotechnology/pharmaceutical/clinical trial management (global experience a plus).
- Familiarity with document filing/management in an eTMF environment.
- Excellent communication and interpersonal skills; strong organizational skills and attention to detail.
- Ability to manage multiple tasks and changing priorities.
- Proficiency in Microsoft Word/Excel.
Travel: Up to 20%
- The Senior Clinical Trial Associate (SCTA) is the central contact for the designated clinical study team, supporting planning, implementation, and completion of clinical studies (outsourced or in-house) via interaction with investigative 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 out the Trial Master File (TMF/eTMF); perform QC as assigned and resolve discrepancies.
- Maintain and update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare agendas and take comprehensive minutes for internal/external meetings.
- Track study activities as assigned (monitor visit tracking, sample tracking, study supplies).
- Assist with materials for investigator meetings, monitor workshops, and the study manual.
- Coordinate with Regulatory Affairs to ensure documents are completed accurately and handed over within requested timeframes ahead of submission deadlines.
- Coordinate cross-functional information/material exchange as assigned.
- Assist with data reconciliation.
- Participate in review of clinical data in the clinical database, data listings, and reports as assigned.
- Update and maintain public clinical trial listings/postings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance (obtain/review policies, track renewals/expiring certificates).
- Prioritize and plan work to meet deadlines; may take on additional study-related responsibilities.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline.
- 2+ years in biotechnology/pharmaceutical/clinical trial management (global experience a plus).
- Familiarity with document filing/management in an eTMF environment.
- Excellent communication and interpersonal skills; strong organizational skills and attention to detail.
- Ability to manage multiple tasks and changing priorities.
- Proficiency in Microsoft Word/Excel.
Travel: Up to 20%