Experienced Clinical Research Associate
Core
Conducting qualification, initiation, monitoring, and closeout visits for clinical research sites to ensure compliance with protocols and regulations.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for drug and medical device development
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical site monitoring, protocol adherence, regulatory document review, adverse event verification, patient recruitment assessment, source data verification, investigator qualification verification, inventory management
Preferred skills
Oncology monitoring experience, Spanish language proficiency, negotiation skills
Technologies
Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits for research sites; Verify investigator qualifications, training, and resources; Review medical records and source documentation against case report forms; Verify eligibility of enrolled subjects; Review regulatory documents and manage product accountability; Assess patient recruitment and retention success; Complete monitoring reports and follow-up letters.
Seniority
Entry-level to Mid-level (1.5 years experience required)
