In-house Sr Clinical Research Associate
Responsibilities
- Support clinical operations across multiple studies while ensuring subject safety and data integrity
- Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines
- Support study start-up and ongoing trial activities, including regulatory documentation and site readiness
- Serve as a liaison between internal teams, CROs, vendors, and investigator sites
- Review monitoring visit reports (PSV, SIV, IMV, COV)
- Remotely track enrollment and treatment status using IxRS and EDC systems
- Maintain study tracking tools, meeting minutes, and action items
- Participate in investigator meetings, study training, and co-monitoring activities as needed
- Perform duties in compliance with FDA regulations, ICH-GCP, and company policies
Required Qualifications
- Bachelor’s degree preferred
- 4 years of In-house CRA experience
- Sponsor experience required
- Site management and CRO/vendor oversight
- Proficiency with Microsoft Office and Veeva eTMF
- Smartsheet and SharePoint a plus
- Phase I–III Experience
- Clinical Resource Network Distinction CRN
About the Role
A clinical-stage biopharmaceutical company in San Diego, California is seeking an experienced Contract Clinical Research Associate (CRA) to support ongoing clinical trials. This is an in-house clinical operations role (not a field monitoring position) with minimal travel required.
Benefits
We offer a comprehensive benefits program for hourly employees, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits.
Opportunity Awaits
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements.