Senior Clinical Trial Associate
Olema Oncology
August 09, 2026
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
Senior Clinical Trial Associate
Responsibilities:
- Support Clinical Trial Lead (CTL) and Study Execution Team (SET) with accurate study documentation.
- Manage study-related vendors; serve as point of contact for contracted CROs, labs, and other vendors.
- Act as key point of contact for investigator sites; facilitate communication and study coordination.
- Oversee sample collection, shipment, and analyses.
- Reconcile and track study processes; escalate issues to study lead.
- Identify risks and proactively resolve issues with CROs.
- Assist with vendor management and study plans; compile study/quality metrics.
- Maintain correspondence with vendors and sites to obtain/provide study information.
- Ensure receipt, completeness, accuracy, and filing of clinical/administrative documents (e.g., Trial Master File, SharePoint, other systems).
- Support central IRB submission documentation and review site-specific informed consent forms.
- Coordinate electronic distribution and/or shipment of study materials.
- Track vendor/site contracts, budgets, invoices, and payments as needed.
- Contribute to TMF plan; perform periodic TMF quality control reviews and reconciliation.
- Perform administrative/clerk duties (agendas, minutes, meeting planning/presentations) and support clinical operations initiatives; may lead SOPs/processes.
Qualifications:
- Bachelor’s degree required.
- 3+ years related industry experience required (Senior CTA requires 2+ years as Clinical Trial Associate).
- Familiarity with FDA/EMA requirements and ICH/GCP preferred; working knowledge of clinical protocols.
Required/Preferred Skills:
- Microsoft Office proficiency (Word, Excel, PowerPoint, Outlook).
- Experience leading small group meetings and/or managing vendor relationships.
- Strong organization, attention to detail, written/verbal communication, teamwork.
- Flexible schedule as needed; ~10% travel.
Compensation/Benefits:
- Base pay range: $100,000–$115,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- None provided.
Responsibilities:
- Support Clinical Trial Lead (CTL) and Study Execution Team (SET) with accurate study documentation.
- Manage study-related vendors; serve as point of contact for contracted CROs, labs, and other vendors.
- Act as key point of contact for investigator sites; facilitate communication and study coordination.
- Oversee sample collection, shipment, and analyses.
- Reconcile and track study processes; escalate issues to study lead.
- Identify risks and proactively resolve issues with CROs.
- Assist with vendor management and study plans; compile study/quality metrics.
- Maintain correspondence with vendors and sites to obtain/provide study information.
- Ensure receipt, completeness, accuracy, and filing of clinical/administrative documents (e.g., Trial Master File, SharePoint, other systems).
- Support central IRB submission documentation and review site-specific informed consent forms.
- Coordinate electronic distribution and/or shipment of study materials.
- Track vendor/site contracts, budgets, invoices, and payments as needed.
- Contribute to TMF plan; perform periodic TMF quality control reviews and reconciliation.
- Perform administrative/clerk duties (agendas, minutes, meeting planning/presentations) and support clinical operations initiatives; may lead SOPs/processes.
Qualifications:
- Bachelor’s degree required.
- 3+ years related industry experience required (Senior CTA requires 2+ years as Clinical Trial Associate).
- Familiarity with FDA/EMA requirements and ICH/GCP preferred; working knowledge of clinical protocols.
Required/Preferred Skills:
- Microsoft Office proficiency (Word, Excel, PowerPoint, Outlook).
- Experience leading small group meetings and/or managing vendor relationships.
- Strong organization, attention to detail, written/verbal communication, teamwork.
- Flexible schedule as needed; ~10% travel.
Compensation/Benefits:
- Base pay range: $100,000–$115,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- None provided.