Clinical Research Associate job in Bethesda at Technical Resources International
Technical Resources International

Responsibilities:

• Provides site management and monitoring support for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV.
• Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
• Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.
• Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
• Assist in protocol, Informed Consent, and CRF design and review.
• Develops and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.
• Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.
• Decisions are made independently and with some supervision from Director, Clinical Operations/Project Management or Project Manager.
• Tasks are primarily intellectual and require exercise of discretion and independent judgment.

Recommended Skills

• Certified Retirement Counselor
• Good Clinical Practices (Gcp)
• Clinical Research Associate
• Operations
• Management
• Decision Making

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