Senior Clinical Research Associate

Join our global team dedicated to innovation and initiative. As a Senior Clinical Research Associate, you will conduct site monitoring responsibilities for clinical trials, provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality.

Requirements

• Provides guidance, oversight, and feedback to the CRA team
• Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed
• Ensures appropriate and timely investigator site visits
• Coordinates with cross-functional departments to facilitate negotiation/issue resolution
• Assists in development of study-specific Monitoring Plans and training presentations
• Performs qualification, initiation, interim, and close-out visits
• Prepares monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
• Ensures integrity of CRF data through source document review and verification
• Conducts investigational product accountability
• Maintains regular contact with study sites to ensure protocol/GCP compliance
• Complies with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
• Participates in internal, client/sponsor, scientific, and other meetings
• Facilitates adverse event reporting and ensures the reconciliation of SAE reports
• Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data
• Proactively identifies site issues and develops problem-solving strategies
• Conducts audit preparation at study sites as needed
• Works with other CRAs to maintain consistency and promote a collaborative team atmosphere
• Performs additional duties as assigned