FSP CRA Level 2
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
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Investigational product inventory, Site initiation, Trial close out, Regulatory compliance, Data review (SDR/SDV/CRF)
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving, Microsoft Office
Technologies
Clinical Trial Management Systems (CTMS)
Responsibilities
Monitor investigator sites using risk-based approaches to identify and resolve compliance issues; Conduct on-site and remote monitoring activities including data verification and product inventory; Initiate and close out clinical trial sites; Ensure essential study documents are complete and audit-ready; Track trial status and provide progress reports to management; Facilitate communication between sites, clients, and project teams.
Seniority
Mid-level IC