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Clinical Operations Supervisor
3 months ago
As a Clinical Operations Supervisor at Alimentiv Inc, you will be responsible for overseeing the clinical operations of various projects at a defined regional or global level.
Key Responsibilities:
- Provide comprehensive oversight of project deliverables, assigned Clinical Research Associates (CRAs), and Investigator sites in alignment with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations.
- Act as the primary liaison between CRAs and the clinical project team, ensuring effective communication and collaboration.
- Conduct project-specific training for CRAs and perform assessment visits to evaluate CRA performance.
- Implement strategies for enrollment and recruitment, prepare monitoring plans, and manage the scheduling of monitoring visits.
- Review and track protocol deviations, ensuring compliance with high-quality project deliverables.
- Proactively manage site and country performance metrics, including recruitment and data collection, and keep the clinical project team informed of progress.
- Contribute to financial project management processes, including site payments and expense reviews.
- Facilitate regular global CRA calls and provide operational support to the monitoring team throughout the project lifecycle.
- Develop training materials and study tools for CRAs and sites, ensuring all study-specific training requirements are met.
Qualifications:
- A college diploma or degree with 7-9 years of relevant experience, or an undergraduate university degree with 4-6 years of experience and substantial ongoing training.
- A minimum of 3 years of CRA experience, with proficiency in EDC systems and MS Office.
- Strong written and verbal communication skills, along with effective interpersonal and organizational abilities.
- Demonstrated understanding of GCPs and local regulations related to clinical monitoring and Investigator responsibilities.
- Proven ability in report writing and critical analysis of clinical research documents.
