Clinical Research Associate
Core
Conduct on-site monitoring visits at clinical research sites to ensure compliance with protocols, GCP, and regulatory requirements for drug and medical device development.
Role type
Senior IC Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceuticals and medical devices
Domain
Clinical research / Biopharmaceuticals / Medical devices
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, Protocol adherence, GCP knowledge, Regulatory document review, Adverse event reporting, Site qualification, Data verification, Patient recruitment assessment, Inventory management
Preferred skills
CRA certification, Travel flexibility, Microsoft Office proficiency
Technologies
Microsoft Office
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits at research sites; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Verify subject eligibility; Review regulatory documents; Manage investigational product accountability; Report adverse events; Assess patient recruitment and retention; Complete monitoring reports.
Seniority
Mid-level, hands-on IC
