Clinical Research Associate - Sponsor Dedicated
Core
Overseeing clinical trial sites to ensure studies are conducted in compliance with protocols, GCP, and ICH guidelines across multiple therapeutic areas.
Role type
Senior IC Clinical Research Associate (CRA)
Builds
Clinical studies for pharmaceutical and biotechnology sponsors
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Site monitoring, patient recruitment, regulatory compliance (GCP/ICH), protocol adherence, data query resolution, TMF/ISF management, cross-functional collaboration
Preferred skills
Therapeutic area knowledge, study start-up experience, budget tracking
Technologies
Microsoft Office, mobile and electronic data capture technologies
Responsibilities
Conduct site selection, initiation, routine monitoring, and close-out visits; Evaluate site performance and adherence to protocols; Partner with sites on patient recruitment strategies; Deliver protocol-specific training; Identify and escalate quality/compliance concerns; Monitor study progress and data completion; Ensure essential study documentation is complete and accurate; Prepare monitoring reports and follow-up letters.
Seniority
Senior, hands-on IC
