Clinical research scientist vs clinical research associate

Differences between clinical research scientist and 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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Clinical research associate example responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.
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