CRA (Level I, Level II and Sr CRA)

Roles & Responsibilities:
• Perform on-site and remote clinical monitoring activities as per monitoring plan
• Ensure protocol compliance, ICH-GCP adherence, and regulatory requirements
• Conduct SDR, SDV, and CRF reviews to ensure data accuracy
• Assess investigational product accountability and site documentation
• Identify site issues, perform root cause analysis, and support CAPA implementation
• Ensure audit readiness and timely issue escalation to clinical management
• Initiate, monitor, and close out clinical trial sites
• Maintain essential documents, TMF completeness, and CTMS updates
• Coordinate with investigational sites, clients, and project teams
• Support investigator meetings, payments, and study progress reporting

Qualification:
• Bachelor’s degree in Life Sciences or related field
• Registered Nursing qualification may also be considered

Experience:
• Minimum 2+ years of experience as an on-site Clinical Research Monitor
• Valid driving license (where applicable)

Skills:
• Strong clinical monitoring and risk-based monitoring knowledge
• Good understanding of ICH-GCP, regulatory guidelines, and medical terminology
• Excellent critical thinking, problem-solving, and RCA skills
• Strong communication, documentation, and interpersonal skills
• Good computer skills (MS Office, CTMS, clinical systems)
• Ability to work independently, manage time effectively, and adapt to change

About the Organization:
Thermo Fisher Scientific, through its PPD clinical research services, supports global clinical trials end-to-end, helping customers deliver high-quality, cost-efficient studies that improve health outcomes worldwide.