Regulatory Specialist

Regulatory Specialist (Hybrid) A Clinical Research Regulatory Specialist works closely with our Clinical Research staff to provide excellent regulatory oversight for our clinical trials. To ensure the integrity and accuracy of all regulatory documentation within the organization. To demonstrate knowledge of Good Clinical Practices and FDA regulations specifically pertaining to the recruitment and retention of study subjects.

Duties & Responsibilities: Prepares, facilitates, and coordinates the process for 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. Follows up, communicates, and facilitates responses to queries of the IRB, Sponsor, and other committees as a result of their review of submissions. Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research.

Obtains Sponsor approval of consent form prior to submission to the IRB. Facilitates and coordinates 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 preparing 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 the 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 matters as assigned by management. Knowledge & Experience: Education: Bachelor's Degree Experience: Have at least one year of experience as a CRC Proven leadership skills in project management, including project management tools and techniques.

FDA, IRB administration, research, and/or regulatory affairs exp. required. Credentials: N/A Knowledge and Skills: Strong written and oral communication skills. Strong computer skills, including Microsoft Office, Excel, and PowerPoint. Ability to manage time-sensitive projects in order to meet deadlines. Strong ability to establish and maintain effective working relationships.