Senior Clinical Trial Associate
Olema Oncology
June 27, 2026
On-site
San Francisco, CA
Clinical Research and Development
About the Role: Senior Clinical Trial Associate
Responsibilities:
- Support the 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, study staff, contract labs, and other vendors.
- Act as key point of contact for investigator sites to facilitate communication and coordination.
- Oversee sample collection, shipment, and analyses.
- Reconcile and track study processes; escalate issues timely to the study lead.
- Identify potential risks and proactively resolve CRO-related issues.
- Assist with vendor management and other study plans; compile study and quality metrics.
- Maintain correspondence with vendors and sites; ensure information is provided/obtained.
- Ensure receipt, completeness, accuracy, and proper filing of clinical/administrative documents (e.g., Trial Master File, SharePoint, other systems).
- Support central IRB submissions and review of site-specific informed consent forms.
- Coordinate electronic distribution/shipment of study materials.
- Help track vendor/site contracts, budgets, invoices, and payments as needed.
- Contribute to TMF plan; perform quality control reviews and TMF reconciliation.
- Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations).
Qualifications (Required/Preferred):
- Bachelor’s degree (required).
- Minimum 3 years of related industry experience (required).
- Senior CTA requires 2 years as a Clinical Trial Associate.
- Familiarity with FDA/EMA regulatory requirements and ICH/GCP (preferred).
- Working knowledge of clinical protocols.
- Proficiency with Microsoft Word/Excel/PowerPoint/Outlook.
- Experience leading small group meetings and/or managing vendor relationships.
Skills/Attributes:
- Highly motivated; works well in fast-paced environments.
- Strong teamwork/collaboration.
- Excellent organization, multitasking, and attention to detail.
- Strong written and verbal communication.
- Flexible schedule as needed for trial priorities.
Benefits/Compensation:
- Base pay range: $100,000–$115,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Not specified.
Responsibilities:
- Support the 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, study staff, contract labs, and other vendors.
- Act as key point of contact for investigator sites to facilitate communication and coordination.
- Oversee sample collection, shipment, and analyses.
- Reconcile and track study processes; escalate issues timely to the study lead.
- Identify potential risks and proactively resolve CRO-related issues.
- Assist with vendor management and other study plans; compile study and quality metrics.
- Maintain correspondence with vendors and sites; ensure information is provided/obtained.
- Ensure receipt, completeness, accuracy, and proper filing of clinical/administrative documents (e.g., Trial Master File, SharePoint, other systems).
- Support central IRB submissions and review of site-specific informed consent forms.
- Coordinate electronic distribution/shipment of study materials.
- Help track vendor/site contracts, budgets, invoices, and payments as needed.
- Contribute to TMF plan; perform quality control reviews and TMF reconciliation.
- Perform study/department administrative tasks (agendas, minutes, meeting planning/presentations).
Qualifications (Required/Preferred):
- Bachelor’s degree (required).
- Minimum 3 years of related industry experience (required).
- Senior CTA requires 2 years as a Clinical Trial Associate.
- Familiarity with FDA/EMA regulatory requirements and ICH/GCP (preferred).
- Working knowledge of clinical protocols.
- Proficiency with Microsoft Word/Excel/PowerPoint/Outlook.
- Experience leading small group meetings and/or managing vendor relationships.
Skills/Attributes:
- Highly motivated; works well in fast-paced environments.
- Strong teamwork/collaboration.
- Excellent organization, multitasking, and attention to detail.
- Strong written and verbal communication.
- Flexible schedule as needed for trial priorities.
Benefits/Compensation:
- Base pay range: $100,000–$115,000 annually; total compensation includes equity, bonus, and benefits.
Application instructions:
- Not specified.