Clinical Research Associate Vs Study Coordinator

Differences between clinical research associate and study coordinator duties and responsibilities

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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Study Coordinator Example Responsibilities.

• Manage and analyze EKG and sleep data collect from subjects in confidential database.
• Establish and maintain strong community partnerships to achieve HIV prevention objectives.
• Conduct consent discussions and other study procedures per protocol and CFR and GCP guidelines.
• Maintain strict patient confidentiality according to HIPPA regulations, GCP and ICH , 21 CFR and other regulatory documentation.
• Maintain accurate IRB, regulatory and study documentation to insure compliance with protocol and good clinical practice guidelines.
• Coordinate day-to-day study activities including data collection and statistical analysis, protocol development/implementation, IRB relations, and staff development.
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