FSP CRA (Level II)
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
Level II Clinical Research Associate (CRA)
Builds
Clinical trials for top 50 pharmaceutical companies and 750+ biotechs
Domain
Life Sciences / Clinical Research
Deliverable
client delivery
Required skills
Risk-based monitoring, root cause analysis, critical thinking, problem-solving, ICH-GCP compliance, site initiation, trial close-out, data review (SDR/SDV/CRF), investigator payment processing, regulatory audit response
Preferred skills
Medical/therapeutic area knowledge, Clinical Trial Management System (CTMS) proficiency, presentation skills
Technologies
Microsoft Office, Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through document review; initiate and close out clinical trial sites; respond to regulatory audits and inspections; track trial status and update study systems; facilitate communication between sites, clients, and project teams.
Seniority
Mid-level IC