Clinical trials specialist vs senior clinical research associate

Differences between clinical trials specialist and senior clinical research associate 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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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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