Sr CRA
Core
Conducts remote or on-site visits to assess protocol and regulatory compliance, manage documentation, and ensure trial conduct aligns with approved protocols and ICH-GCP guidelines for clinical trials.
Role type
Senior Clinical Research Associate (CRA)
Builds
Clinical trial data reliability and subject safety across global studies
Domain
Clinical research / Life sciences
Required skills
Risk-based monitoring, root cause analysis, FDA guidelines knowledge, ICH-GCP compliance, medical terminology, data accuracy review, site initiation, investigator management, regulatory audit response
Preferred skills
Critical thinking, problem-solving, digital literacy, presentation skills, process improvement
Technologies
Clinical Trial Management System (CTMS), Microsoft Office
Responsibilities
Monitor investigator sites using risk-based approaches; ensure data accuracy through SDR, SDV, and CRF review; initiate and close out clinical trial sites; conduct on-site file reviews; respond to regulatory audits and inspections; facilitate communication between sites, clients, and project teams.
Seniority
Senior, hands-on IC