Backed by 5AM Ventures.
About the role
Reporting to the Senior Director, Clinical Operations, the Sr. Clinical Research Associate (Sr. CRA) provides hands-on site monitoring and site management for assigned clinical trials from site identification and activation through closeout. The Sr.
What they're looking for
- Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or an equivalent combination of education and relevant experience
- Minimum of 5+ years of site monitoring experience as a CRA
- Experience in pain trials across study startup, conduct, and closeout
- Working knowledge of ICH GCP, applicable FDA regulations, and other regulatory requirements governing clinical trial conduct
- High level of attention to detail and ability to evaluate source documentation, identify compliance and data-quality risks, write high-quality monitoring reports, and drive follow-up actions to closure
- Experience working with CTMS, eTMF, EDC, IRT, and Microsoft Office applications
More about this role
Position Summary
Reporting to the Senior Director, Clinical Operations, the Sr. Clinical Research Associate (Sr. CRA) provides hands-on site monitoring and site management for assigned clinical trials from site identification and activation through closeout. The Sr. CRA serves as a primary operational contact for investigative sites, verifies that trial activities are conducted in accordance with the protocol, monitoring plan, applicable regulations, ICH GCP, and company procedures, and drives timely resolution of site-level risks and issues. The role may also support study-level operational activities and provide guidance to less-experienced CRAs.
Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area.
- Perform oversight of site qualification, initiation, interim monitoring, and closeout visits, remotely and on site, in accordance with the monitoring plan and applicable procedures.
- Confirm investigator site readiness, including facilities, staffing, essential documents, training, investigational product processes, laboratory requirements, and required systems access.
- Review informed consent documentation, eligibility, safety reporting, investigational...
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