Clinical Research Associate - Life Science Degree
Core
Conduct qualification, initiation, monitoring, and closeout visits at clinical research sites to ensure compliance with protocols and regulations 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
Life Sciences / Clinical Research / Pharmaceuticals
Required skills
Site monitoring, regulatory compliance (GCP/SOPs), data verification, adverse event reporting, patient recruitment assessment, documentation review, travel management
Preferred skills
Biomedical Engineering degree, healthcare-related work experience, risk-based monitoring approach
Technologies
Integrated Clinical Trial Management System, Microsoft Office
Responsibilities
Conduct on-site and virtual monitoring activities to identify site deviations and ensure compliance; Verify investigator qualifications, training, and resources; Review medical records and source documentation against case report forms; Assess patient recruitment and retention success; Report adverse events and serious adverse events accurately; Complete monitoring reports and follow-up letters.
Seniority
Entry-level to Junior, training program focused
