Clinical Research Associate (Biomedical Engineering Candidates)
Core
Conduct qualification, initiation, monitoring, and closeout visits at research sites to ensure compliance with protocols and regulatory requirements for pharmaceutical and medical device development.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for biotechnology, pharmaceutical, and medical device companies
Domain
Clinical Research / Biomedical Engineering / Healthcare
Deliverable
client delivery
Required skills
Medical record verification, protocol deviation management, risk-based monitoring, regulatory document review, adverse event verification, site qualification, investigator enrollment verification
Preferred skills
Biomedical Engineering degree, healthcare-related work experience, Microsoft Office proficiency
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Conduct on-site and virtual monitoring activities to identify site deviations and implement corrective actions; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Entry-level to Junior, training program participant
