Research Regulatory Manager

Summary

Manage clinical and development functions of a clinical trials and/or drug studies center or a major group of clinical trials and/or drug studies.  Supervise professional and non-professional staff in the day to day management of clinical trials and drug studies.  Serve as a resource for all faculty and staff in the regulatory approval processes.  Develop and implement procedures for managing trials, reviewing budgets, and complying with regulatory requirements.

Examples of Work

Job functions are specific duties that would be included in the essential functions of the job description.  These functions are not all-inclusive nor do they cover the full extent of the duties performed.

• Coordinates the acquisition of tissue samples; obtains pertinent preliminary clinical information on study patients and maintains clinical database responsible for the development of educational and support material in various media for brain tumor patients and their families.
• Researches, develops, and implements appropriate protocols for the identification, shipment and storage of specimens.
• Acts as liaison with members of internal and external advisory councils and reports on progress of the center or group.  Serves as liaison to members of the press, participating institutions, legislators etc. in all matters related to the center or group.
• Responsible for overall management of center or group meetings, as well as meetings of applicable scientific advisory councils.
• Participates in the development of educational and support material for patients; and assists in advising and interpreting procedures and outcomes to patients.
• Conducts investigations and audits of potential research compliance violations and implements corrective action, as appropriate.
• Conducts risk assessments to identify potential areas of risk and to determine activities at greatest risk to ensure proper compliance; conducts monitoring and quality assurance reviews to determine level of compliance; makes recommendations to management, as appropriate or requested.
• Conducts investigations and audits of potential research compliance violations and implements corrective action, as appropriate.

Education and Experience

Bachelor’s degree and four years of appropriate experience; or an equivalent combination of education and experience.

Licensure and Certification

N/A

Supervision

This position does include supervisory responsibility.

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