Clinical research administrator vs study director

Differences between clinical research administrator and study director 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 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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