Study coordinator vs senior clinical research associate

Differences between study coordinator and senior clinical research associate duties and responsibilities

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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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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