Research Regulatory Affairs Specialist

Key Performance AreasKPA 1 – Creates and maintains central regulatory files in accordance with site SOP.

Adhere to and maintain working knowledge of FCS practice policies, the Federal regulations, ICH, and GCP guidelines. In compliance with the Code of Federal Regulations under the Health Insurance Portability and Accountability Act (HIPAA), assure that patient records will be kept confidential and secure. Collect and maintain study specific documentation in the appropriate Regulatory Binder as well as the electronic document system including:

• Create and maintain the FCS Research Delegation of Authority logs and role specific profiles, ensure revised profiles to investigators and research staff as roles and responsibilities necessitate.
• Create and maintain study‑specific FDA Form 1572, ensure form is reconciled and updated as change necessitates.
• Collect and maintain Financial Disclosure Forms as completed by investigators, elevate reported disclosures to leadership if reported.
• In collaboration with various departments, maintain historical credentials all current and previous Investigators and research staff, laboratory licenses, CLIA/COLA. Produce as needed for Sponsor/CRO review.
• Maintain credible documentation by using ALCOAC method (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
• Support GCP and protocol specific training for staff and investigators by:
  Upload and archive protocol specific training modules for all studies.
• According to site SOP, distribute training module assignments and maintain documentation GCP training for all research staff and investigators.

Prepare and ensure timely reporting and submissions to IRB in accordance to site SOP and federal regulations including:

• Ensure IRB approval is obtained at study activation and maintain in the Regulatory Binder
• Obtain documentation of IRB approvals, including amendments and revision to study related documents, such as revised informed consents and protocols and maintain in the Regulatory Binder.
• Complete the IRB Continuing review reports required by the IRB and submit to the applicable IRB.
• File all correspondence regarding continuing review report submission in the Regulatory Binder.
• Ensure the process is followed for reporting any Serious Adverse Event (SAE) to the IRB that meets IRB reporting guidelines, as determined by the PI.
• Notify the Research Coordinators via email when a new/amended Protocol or ICF has been IRB approved.
• Ensure research coordinators are provided IRB instructions for reconsenting subjects in timely manner.
• Review signed ICFs for completeness and notify the Research Coordinator of any discrepancies.
• Maintain internal log of consent versions.
• Maintain a master subject/enrollment list electronically for each study until the study is terminated and records are ready to archive.

Conduct on‑site and remote monitoring activities through:

• Prepare for interim monitoring visits (IMV) by ensuring the Regulatory Binder is complete prior to IMV.
• When discrepancies are noted during the monitoring visit, work collaboratively with the Sarah Cannon Regulatory Department to ensure any noted discrepancies are corrected.
• Request that the monitor summarize any findings, issues or concerns during the visit in a follow‑up letter and note status of resolution.
• Meet with the Sponsor representative as needed during visits to ensure issues are resolved appropriately and in a timely manner.
• Maintain the Site Visit Log and ensure monitors complete the log prior to departure.
• Following the IMV, review monitor report/letters and forward to appropriate staff for review.
• Ensure all identified issues are addressed prior to the next monitoring visit.
• Maintain a copy of the letters in the Regulatory Binder Termination and Closeout activities Will schedule, prepare, and conduct the Study Termination Visit.
• Prior to scheduled Study Termination Visit, ensure all study documents are filed and any discrepancies are addressed in a NTF.
• Send required…