Sr. Clinical Trial Assistant - Bay Area
Structure Therapeutics
14 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
The Senior Clinical Trial Associate (SCTA) supports the planning, implementation, and completion of clinical studies (outsourced or in-house) by serving as a central contact for the designated clinical study team and interacting with investigative sites, vendors, and internal 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 Trial Master File (TMF/eTMF); perform QC and resolve discrepancies.
- Maintain/update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare meeting agendas and take comprehensive minutes (internal/external).
- Support study-level tracking (monitor visit tracking, sample tracking, study supplies, etc.).
- Assist with materials for investigator meetings, monitor workshops, and the study manual.
- Coordinate with team members to ensure accurate document completion by Regulatory Affairs; hand off completed documents within requested timeframes.
- Interface with cross-functional groups for timely exchange of information/materials.
- Assist with data reconciliation; participate in review of clinical data listings/reports as assigned.
- Update/maintain public clinical trial listings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance policies (obtain/review, track renewals).
- Prioritize and plan work to meet deadlines; may perform additional study-needed responsibilities.
Qualifications
Education
- Bachelor’s degree in a relevant scientific discipline.
Experience
- 2+ years in biotechnology/pharmaceutical/clinical trial management (global experience a plus).
- Familiarity with document filing/management in an eTMF environment.
Required/Preferred Skills
- 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) supports the planning, implementation, and completion of clinical studies (outsourced or in-house) by serving as a central contact for the designated clinical study team and interacting with investigative sites, vendors, and internal 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 Trial Master File (TMF/eTMF); perform QC and resolve discrepancies.
- Maintain/update study metrics (visit reports, regulatory documents, site/team contact lists, vendor lists, etc.).
- Prepare meeting agendas and take comprehensive minutes (internal/external).
- Support study-level tracking (monitor visit tracking, sample tracking, study supplies, etc.).
- Assist with materials for investigator meetings, monitor workshops, and the study manual.
- Coordinate with team members to ensure accurate document completion by Regulatory Affairs; hand off completed documents within requested timeframes.
- Interface with cross-functional groups for timely exchange of information/materials.
- Assist with data reconciliation; participate in review of clinical data listings/reports as assigned.
- Update/maintain public clinical trial listings (e.g., clinicaltrials.gov, EUdract).
- Assist with clinical trial insurance policies (obtain/review, track renewals).
- Prioritize and plan work to meet deadlines; may perform additional study-needed responsibilities.
Qualifications
Education
- Bachelor’s degree in a relevant scientific discipline.
Experience
- 2+ years in biotechnology/pharmaceutical/clinical trial management (global experience a plus).
- Familiarity with document filing/management in an eTMF environment.
Required/Preferred Skills
- 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%.