Clinical Research Associate II (CRA II) – FSP Business Unit
Core
Conduct remote and on-site clinical monitoring and site management to ensure protocol and regulatory compliance, data accuracy, and subject safety across global pharmaceutical trials.
Role type
Senior IC Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical sponsors
Domain
Life Sciences / Clinical Research / Pharma
Required skills
Clinical monitoring, Risk Based Monitoring (RBM), Root Cause Analysis (RCA), ICH-GCP guidelines, Protocol adherence, Site initiation and close-out, Investigational product inventory, Regulatory compliance, Data review (SDR/SDV/CRF), Travel management
Preferred skills
Medical/therapeutic area knowledge, Microsoft Office proficiency, English language fluency
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 essential study documents; Facilitate communication between sites, clients, and project teams; Respond to regulatory audits and inspections.
Seniority
Mid-level, hands-on IC