Independently manage assigned clinical trial sites from start-up through close-out
Perform site qualification, initiation, routine monitoring, and close-out visits
Ensure subject safety, data integrity, and protocol compliance at all assigned sites
Review source documentation, CRFs, and EDC entries for accuracy, completeness, and timeliness
Serve as the primary point of contact for investigators and site staff
Build strong, collaborative relationships with site teams
Identify site performance issues early and implement corrective actions
Ensure compliance with ICH GCP, FDA regulations, ISO 14155 (as applicable), and internal procedures
Support audits and inspections as a subject matter expert
Mentor and provide functional guidance to junior CRAs and CTAs
Partner closely with Clinical Operations, Quality, Regulatory, Data Management, and Medical Affairs

Bachelor’s degree in life sciences, nursing, or related field (Master’s preferred)
7–10+ years of progressive clinical research experience as a CRA
Demonstrated ability to manage sites independently with minimal supervision
Extensive experience monitoring Phase I–IV clinical trials and/or medical device studies
Strong working knowledge of ICH GCP, FDA regulations, and applicable ISO 14155 standards
Proven experience supporting audits and regulatory inspections
Prior experience serving as a Lead CRA or Senior CRA on multiple studies (preferred)
Experience mentoring or leading junior CRAs (preferred)
Medical device and/or reimbursement study experience (preferred)

Senior Clinical Research Associate

Key skills