Clinical Trial Associate
Technical Resources International

Job Info

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Responsibilities:

• Triage incoming emails, either as HelpDesk or other centralized/group email box.
• Process/track/distribute/upload designated clinical trial documents/artifacts, e.g., protocol deviations, site monitoring visit reports, essential regulatory documents (ERDs), etc. Generate/distribute Monthly/Quarterly reports regarding the documentation to internal and/or external stakeholders.
• Review information in centralized databases, e.g., patient recruitment/accrual, clinical data entered as EDC. Resolve queries, provide analysis assessments, and create/distribute periodic reports to internal and external stakeholders. Participate in centralized monitoring visits (CMVs).
• Provide Meeting/Webinar Support, i.e., distribute invites, track attendance, and complete/distribute meeting minutes/summaries to internal and external parties.
• Adherence to strict project timelines and expectations.
• Troubleshoot issues by applying existing knowledge to solve new problems.

Job Requirements
Requirements:

• B.A/B.S. in health-related field preferred, or understanding of data and/or documentation handling
• Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
• Must have excellent time management skills.
• Able to identify activities along critical paths toward a specified deliverable.
• Able to negotiate with stakeholders, e.g., investigators, research nurses, and site staff to reach desired goal.
• Demonstrated understanding of medical and clinical trials terminology.
• Able to work independently or with minimal supervision and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency.
• Demonstrated understanding of sponsor-specific requirements, and Standard Operating Procedures/Project Work Instructions.
• Excellent professional writing and verbal communication skills.
• Must be self-motivated and have a positive attitude.
• Excellent organizational and coordination skills with strong attention to detail.

This job has expired.