Senior Clinical Trial Assistant (Sr. CTA) - Clinical Development Operations
Location: San Francisco / South San Francisco, CA (Hybrid - 3 days onsite/week; remote considered)
Our client is a clinical-stage biotech developing small molecule medicines using structure-based and computational drug discovery. They’re building out their Clinical Development Operations function and need a strong Sr. CTA to support late-phase clinical study execution in a smaller-company environment.
What you’ll do
- Own study document collection/tracking (CVs, 1572s, IRB approvals, lab certs, contracts, protocols, etc.).
- Set up/maintain/close out TMF/eTMF; run QC and fix discrepancies.
- Maintain core study trackers/metrics (contacts, vendor lists, visit reports, monitoring visit tracking, samples, supplies).
- Build agendas and capture clean, actionable meeting minutes (internal + external).
- Support investigator meetings, monitor workshops, and study manuals.
- Coordinate document workflows with Regulatory Affairs to hit submission timelines.
- Support data reconciliation and help with database/listing review as assigned.
- Maintain clinical trial public postings (e.g., ClinicalTrials.gov, EU registries).
- Support clinical trial insurance documentation and renewals.
What they’re looking for
- Bachelor’s degree (science or related).
- 2+ years of clinical trial operations experience in biotech/pharma (sponsor experience preferred).
- eTMF experience (filing, QC, and inspection readiness mindset).
- Sharp organization, high attention to detail, and comfort juggling priorities.
- Strong communication skills with study teams, sites, and vendors.
- Microsoft Office proficiency.
- Travel up to ~20%.
Compensation
- Target contract pay rate: up to $60~$70/hr (some flexibility).
