Regulatory Manager

Regulatory Manager

The Regulatory Manager will work closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials.

DUTIES & RESPONSIBILITIES

• Completing DMCR-required training, including GCP and IATA.
• Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Oversees the preparation, facilitation and coordination of accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
• Ensures that all documents are complete and that the submission packet meets the IRB's revision submission requirements prior to sending to the IRB.
• Oversees the communications and responses to queries of the IRB, Sponsor and other committees as a result of their review of submissions.
• Oversees the coordination of the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state and local agencies governing biomedical research.
• Ensures Sponsor approval of consent form prior to submission to the IRB.
• Oversees the facilitation and coordination of the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.
• Ensures that regulatory binders are audited and maintained. Tracks workload and status of pending protocols and associated supporting documents in order to provide efficient customer service to the Research team.
• Participates in quality assurance (QA) and control programs related to overall project and patient data, as needed.
• Oversees QA initiatives for the department to support research staff and leaders during sponsor and FDA audits
• Any other tasks as assigned by the line manager.

KNOWLEDGE & EXPERIENCE

Education:

Experience:

• 3+ years of FDA, IRB administration, research, and/or regulatory affairs Required.
• 2+ years of experience as a CRC or Regulatory Specialist.
• Personnel/Team Management Experience Required.

Credentials:

Knowledge and Skills:

• Proficient in advanced computer skills; including Google Suite, Microsoft Office, Excel and PowerPoint.
• Proactive strong organizational skills.
• Excellent verbal and written interpersonal skills.
• Strong written and oral communication skills.
• Proven leadership skills in project management, including project management tools and techniques.
• Ability to manage time sensitive projects in order to meet deadlines.
• Strong ability to establish and maintain effective working relationships