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Job Details


Labcorp (Drug Development)

Regulatory Spec I (2233622)

Pharmaceuticals

All

Yearly

Full Time

No

Madison, Wisconsin, United States

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.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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