Coordinator Regulatory NCH Research Institute

• LOCATION:
  
  350 7th Street North, Naples, FL, 34102
• WORK TYPE:
  Full Time
• WORK SCHEDULE:
  
  8 Hour Day
• DEPARTMENT: 68306 - NPG Research

NCH is an independent, locally governed non‑profit delivering premier comprehensive care. Our healthcare system is comprised of two hospitals, an alliance of 700+ physicians, and medical facilities in dozens of locations throughout Southwest Florida that offer nationally recognized, quality health care. NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to:
Provide higher acuity care and Centers of Excellence;
Offer Graduate Medical Education and fellowships;
Have endowed chairs;
Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and Pro Scan. Join our mission to help everyone live a longer, happier, healthier life. We are committed to care and believe there's always more at NCH - for you and every person we serve together. Visit nchjobs.org to learn more.

The Coordinator Regulatory works with the Manager of NCHRI, to complete all regulatory documents required for participation in clinical trials. These documents must be executed accurately and efficiently. The position requires attention to detail and strict compliance with Good Clinical Practice (GCP). Documents are collected and organized in such a way that retrieval for review is easy and orderly in that they support successful FDA audits.

Both IRB and FDA processes must be clearly documented. This position organizes and maintains the regulatory files for the Institute and assures limited access to only employees of the Research Institute. This role requires strong communication skills and problem‑solving abilities. As the regulatory demands for the clinical trials are ever‑changing, the candidate must be able to adjust accordingly. The Coordinator Regulatory performs administrative duties;

prepares correspondence; interfaces and acts as a liaison to both internal and external customers including senior management. Participates in projects and related activities that are sensitive and confidential in nature which include data entry, compliance tracking, reporting, invoicing, and ordering. Organizing lunch (and/or other) events for conference room attendees when requested – to include ordering the lunches, organizing the display/setup, breaking down and cleaning up after the event.

Other duties may be assigned.

• Manages regulatory activities for all stages of clinical trials. Prepare and submit regulatory documents to Sponsor and IRB and works with clinical research team to ensure submission documents are up‑to‑date.
• Maintains a working knowledge of all federal, state, and institutional guidelines regarding clinical trials. Provide guidance and training to research staff to ensure compliance with rules and regulations associated with clinical research studies.
• Prepares and submits start‑up regulatory packets to Sponsor and IRB.
• Assists leadership with expeditated study launch.
• Responsible and point of contact for submissions of all IRB related correspondence for all protocols to include, initial submissions, protocol amendments, informed consent changes, annual reviews, adverse events, and close out visits.
• Assists with study start up activities to include reporting and communicating with Sponsor, IRB, and site.
• Serve as a liaison to Sponsor/CRO/IRB/Investigators assuring continuity of service and problem resolution.
• Monitors approval status of open studies by completing timely reviews.
• Maintains master files of all regulatory‑related items.
• Coordinates and schedules on‑site visits including introductions tours, EMR access and Sponsor/CRO requests and monitor visits.
• Informs/updates physicians of trial initiations and updates by obtaining required signatures.
• Provide the team with all essential items to start, maintain and close out trials.
• Facilitates Principal Investigator’s oversight of data, timely training completion, signing of required documents, and promotion of patient enrollment.
• Orchestrate sand ensures all training is completed…