Clinical research administrator vs study coordinator

Differences between clinical research administrator and study coordinator duties and responsibilities

Clinical research administrator example responsibilities.

• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Ensure effective data management and the following of good clinical practice (GCP) guidelines.
• Initiate the development of standard operating procedures for regulatory compliance monitoring and auditing of regulatory and IRB documentation.
• Assist with reports and documents to FDA.
• Train new site personnel on specific clinical trial procedures and appropriate FDA regulations.
• Develop and implement program for continual review and quality assessment of regulatory and IRB documentation.
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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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