Clinical Research Associate II (FSP)
Core
Conduct remote or on-site clinical monitoring and site management to ensure protocol and regulatory compliance for pharmaceutical and biotech clinical trials.
Role type
Clinical Research Associate (Level II)
Builds
Clinical trial data integrity and regulatory compliance for top 50 pharma companies and 750+ biotechs
Domain
Life Sciences / Clinical Research / Pharmaceutical
Required skills
Clinical monitoring, Root cause analysis, Risk-based monitoring, ICH GCP knowledge, Data accuracy review (SDR/SDV/CRF), Investigative site identification, Trial close out
Preferred skills
Medical/therapeutic area knowledge, Critical thinking, Problem-solving
Technologies
Clinical Trial Management Systems
Responsibilities
Monitor investigator sites using risk-based approaches; Ensure data accuracy through document review; Escalate and resolve deficiencies; Conduct on-site file reviews; Perform trial close out and material retrieval; Initiate clinical trial sites; Provide trial status reports.
Seniority
Mid-level, hands-on IC
