Position Summary
Under the direction of the Operations Manager and Clinical Research Director, the Regulatory Lead is responsible for coordination of regulatory processes and activities. These include but are not limited to creating, submitting, and filing regulatory documents including serious adverse events, assisting Director and Managers with defined duties such as maintaining the electronic filing system, submitting documents to the IRB and creating and updating informed consents, and review and revision of departmental standard operating procedures. The lead is expected to collaborate effectively within the Clinical Research department to promote regulatory readiness, provide specific guidance and assist in developing plans for adherence as needed. The Regulatory Leader is expected to support and engage in process improvement and to have knowledge and adhere to research institutional policies and research department standard operating procedures. The Regulatory Lead will assist Director and Managers with duties as assigned.
Minimum Requirements
Education
Experience
License/Registration/Certifications
Preferred Requirements
Preferred Education
Preferred Experience
Preferred License/Registration/Certifications
Core Job Responsibilities
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