Experienced Clinical Research Associate
Core
Conduct on-site monitoring visits for clinical trials in rare diseases, cell and gene therapy, and other therapeutic areas to ensure data integrity and regulatory compliance.
Role type
Junior Clinical Research Associate (CRA)
Builds
Clinical trial data and patient safety records for biotechnology and pharmaceutical clients
Domain
Clinical Research / Healthcare / Biopharma
Deliverable
client delivery
Required skills
Clinical trial monitoring, regulatory compliance (ICH GCP), medical terminology, patient recruitment assessment, adverse event verification, site qualification, source data verification
Preferred skills
Background in nursing, pharmacy, or science, knowledge of drug therapy techniques
Technologies
Clinical trial management systems, case report forms
Responsibilities
Conduct qualification, initiation, monitoring, and closeout visits; Verify investigator qualifications and resources; Review medical records and source documentation against case report forms; Verify subject eligibility; Review adverse events and concomitant medications; Assess patient recruitment and retention; Complete monitoring reports and follow-up letters
Seniority
Junior, entry-level IC