Clinical research scientist vs senior clinical research associate

Differences between clinical research scientist and senior clinical research associate duties and responsibilities

Clinical research scientist example responsibilities.

• Supervise and manage planning, implementation, conduct and reporting of assign early phase international clinical studies in oncology.
• Facilitate IRB approval, when require.
• Compile and submit reports to U.S. FDA.
• Provide draft responses to FDA questions to senior management.
• Resolve IRB issues and implement IRB mandate changes in the protocol with amendments.
• Recruit investigators perform pre-study visits, negotiate budgets, initiate and monitor studies and verify data for accuracy and completeness.
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Senior clinical research associate example responsibilities.

• Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
• Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
• Monitor U.S. sites in accordance with ICH and GCP guidelines.
• Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
• Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
• Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
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