Clinical Research Associate (CRA)
Core
Conduct on-site monitoring visits for clinical trials of drugs and medical devices to ensure compliance with protocols and regulations.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and medical device development
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical monitoring, protocol adherence, source data verification, adverse event reporting, regulatory document review, patient recruitment assessment, investigational product accountability
Preferred skills
CRC experience, clinical patient management, ISF preparation, TMF reconciliation
Technologies
Case Report Forms (CRF), Trial Master File (TMF), Investigator Site File (ISF)
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits for research sites; Verify investigator qualifications and resources; Review medical records and source documentation against CRF data; Verify eligibility of enrolled subjects; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Mid-level IC