CRA (Level II) for FSP
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 / Pharma
Deliverable
client delivery
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP regulations, Protocol adherence, Site initiation and close-out, Investigational product inventory, Data review (SDR/SDV/CRF), Regulatory audit response
Preferred skills
Neurology therapeutic area knowledge, Rare Diseases therapeutic area knowledge
Technologies
Clinical Trial Management Systems (CTMS), 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 verification and inventory checks; Initiate and close out clinical trial sites; Ensure essential study documents are complete and compliant; Provide trial status tracking and progress reports to management; Respond to regulatory audits and inspections.
Seniority
Mid-level IC (Level II)