Clinical trials specialist vs study coordinator

Differences between clinical trials specialist and study coordinator duties and responsibilities

Clinical trials specialist example responsibilities.

• Manage all clinical data and subject source documentation through the EDC system to verify compliance and subject eligibility.
• Lead study data management activities for oncology trials in preparation for study close-out.
• Review clinical study documents for completeness and compliance with protocol, FDA regulations, ICH and GCP guidelines.
• Perform routine quality control (QC) of TMF and submit documents to ensure overall quality.
• Review ICF and study reports and find discrepancies that are missed by CRO management.
• Collect, review, approve and track in CTMS regulatory essential start-up and amendment documents.
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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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