FSP CRA (Level I)
Core
Conduct remote and on-site clinical monitoring to ensure protocol and regulatory compliance, manage site processes, and guarantee data reliability for pharmaceutical and biotech clinical trials.
Role type
Junior Clinical Research Associate (Level I)
Builds
Clinical trial data and compliance for pharmaceutical and biotech sponsors
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, data verification (SDR/SDV/CRF), regulatory compliance (ICH-GCP), site initiation, trial close-out, medical terminology, ICH-GCP guidelines
Preferred skills
None stated
Technologies
Clinical Trial Management Systems, Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; conduct on-site and remote monitoring activities including data review and inventory checks; initiate and close out clinical trial sites; prepare and maintain essential study documents; provide trial status tracking and progress reports; facilitate communication between sites, clients, and internal teams.
Seniority
Junior, hands-on IC