FSP CRA (Level II)
Core
Conducts remote and on-site clinical monitoring and site management to ensure protocol compliance, data accuracy, and subject safety in global clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data and regulatory compliance for pharmaceutical and biotech clients
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | 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, Regulatory compliance, Data review (SDR/SDV/CRF), Site selection
Preferred skills
Life sciences degree, Registered Nursing certification, Medical terminology knowledge, Clinical Trial Management Systems (CTMS), Microsoft Office
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 review and inventory checks; Initiate and close out clinical trial sites; Ensure audit readiness and maintain required documentation; Facilitate communication between sites, clients, and project teams; Participate in investigator meetings and site selection processes.
Seniority
Mid-level, hands-on IC