Senior clinical research associate vs study director

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

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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Study director example responsibilities.

• Design, conducts and manages studies for EPA and oce compliance, such as water solubility and partition coefficient studies.
• Manage all outsource toxicology studies at contract research laboratories.
• Establish and maintain strong community partnerships to achieve HIV prevention objectives.
• Evaluate study design and toxicology data as needed.
• Consult drug development scientists on data interpretation and study conclusions for FDA submission.
• Participate on the ISO certification team.
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