What are the responsibilities and job description for the Regulatory Spec I position at Labcorp?
This is an office -based position.
Responsible to provide overall regulatory support to clients, staff, and to maintain regulatory and IRB records associated with clinical studies conducted in clinical pharmacology.
Duties and Responsibilities:
- Provide assistance to staff and clients regarding regulatory responsibilities, where appropriate.
- Maintain accurate and complete regulatory documents for all clinical studies conducted in the division of clinical pharmacology.
- Responsible for weekly filing of Study Master Files and document submission for Trial Master Files
- Assist with regulatory training for staff as needed.
- Coordinate and maintain regular updating of Covance CRU personnel and consultant CVs.
- Coordinate the completion and accuracy of the Staff Signature Sheet.
- Be knowledgeable about regulatory and related clinical operations SOPs.
- Facilitate Consent Form preparation for clinical studies that conform to current regulatory requirements and SOPs. Incorporate necessary medical information as provided by the Investigator’s Brochure/package insert, the Principal Investigator, the Study Manager and/or the client.
- Prepare regulatory documents and IRB submissions for all clinical studies.
- Track and route all incoming and outgoing regulatory correspondence.
- Track status of pending studies for IRB review.
- Submit all required initial and revised study documents, including advertising, protocol, Investigators Brochure, and Consent Forms for IRB approval throughout the course of the study.
- Facilitate the tracking and reporting of all Unanticipated Problems and/or serious adverse events to the IRB.
- Ensure sponsor safety letters are submitted to the IRB, as appropriate.
- Track, prepare and submit interim reports and final summaries to the IRB.
- Oversee preparation of all closed study files for archiving in long term storage.
- Assist with implementation of and adherence to all components of quality programs.
- Assist with maintenance of staff training records and ensure compliance with training programs.
- Maintain exemplary client communication with regard to the consent form, and total IRB review and approval process.
- Consult with clients with regard to consent form language.
- Ensure all Study Master Files are maintained according to SOPs and regulatory requirements.
- Ensure all Trial Master File documents are forwarded as appropriate.
- Liaise with independent IRBs as required to schedule appropriate reviews and ensure all appropriate documents are prepared for submission.
- Ensure appropriate follow-up with independent IRBs.
- Assist Study Managers with all IRB communication.
- Participate in, and contribute to, Regulatory Specialists teleconference meetings on a regular basis.
- Submit monthly reports on IRB metrics, and/or other information, as requested.
- Perform other related duties as assigned.
Requirements:
- BS or BA in medical or related field.
- 0-1 years related experience
- Additional experience may be substituted for education requirements.
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