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

About Nch

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 ProScan.

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.

Job Summary

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.

Essential Duties And Responsibilities

– 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 by research team as well as interdisciplinary team involved, such as physicians, radiology, echo, pharmacy, laboratory, etc.
Facilitates/coordinates/communicates research processes with the ancillary departments such as billing/coding, cath lab, laboratory, physicians across therapeutic areas involved in trials.
Receives, maintains, and monitors device accountability for all trials and ensures it is stored securely.
Participates in Marketing the Research Institute by developing and maintaining a marketing packet for potential future trials acquisition.
Collaborates with NCH Marketing team.
Maintains the Research website/landing page.
Develops and maintains Research Newsletter distributed to NCH institution.
Ensures patients prior authorizations obtained as necessary prior to procedure/case.

Administrative Duties/Oversight

Organizes and maintains order of all regulatory files and documents for each individual protocol to assure Research Institute is “FDA Ready” at all times.
Serves as the primary regulatory officer, responsible for the completeness and accuracy of all regulatory documents, maintaining their confidential status; meets with auditors from Sponsor companies during on site compliance meetings and guides them through the inspection of their respective regulatory project files.
Works with Manager and proposes solutions to non-compliance risks
Instrumental in creating and maintaining reports and files on project workflow and compliance in accordance with GCP and federal compliance laws.
Oversees the development, completeness, and accuracy of Standard Operating Procedures (SOPs); works with the Manager to verify key operations are recorded and are available for staff as well as project sponsors; Participates in annual review of content and update.
Develops statistical reports and reference tools that provide operational data on number of trials, approval status and dates, enrollment performance, sponsor names and CROs associated with approved trials.
Strong partner with the NCH IRB in assuring meetings and Research submissions and presentations are complete and available; completed IRB projects are sent within acceptable within the required IRB submission period
Reports and interprets protocols deviations as well as serious adverse events and relatedness to the investigational products to the NCH IRB and study sponsor
Works with Managers to obtain administrative and physician signatures on all project contracts
Educator of new staff in all areas of regulatory, assists new and current staff in completion of new documents required for compliance and competency.
Assigns and delegate duties to Research Assistant, Data Abstractor, and Research Associate and provides guidance and monitoring to ensure projects are completed timely and accurately.
Serves as a point of contact for all members of the team in relation to initial onboarding to workflow and dynamics of the office.
Managing calendars by scheduling and coordinating appointments, meetings, and travel arrangements for the team. This includes prioritizing, conflict resolution, and ensuring timely attendance.
Communicates and corresponds by handling incoming and outgoing communications on behalf of leadership including phone calls, emails, and memos. Drafting and preparing documents, presentations, and reports.
Organize and maintain files, records, and documents. Ensuring information is readily available and easily accessible when needed.
Arrange and prepare for meetings, including coordinating logistics, preparing agendas, taking minutes, and distributing materials. Follow up on action items and ensure timely completion.
Acts as a point of contact between leadership internally/externally including staff, clients, vendors, and partners.
Builds and maintains relationships to facilitate effective communication.
Overall office management by overseeing day-to-day administrative tasks.
Project support with assisting special projects or initiatives as assigned which will involve coordinating teams, monitoring progress, and ensuring deadlines are met.
Assist with Excel spreadsheets and PowerPoint presentations as needed.
Assist team with utilizing/building Epic research module.
Correspond with sponsors to obtain Epic Care access in preparation of monitor visits.

Education, Experience And Qualifications

Minimum of Bachelor’s degree required.
Minimum 2 years administrative, clerical, or operations experience required; healthcare preferred.
Strong oral, written, and presentation communication skills.
Excel at directing, working, and communicating with internal and external staff of all levels.
Excel both at working independently and in a team-oriented, collaborative environment.
Able to conform to shifting priorities and timelines with continuous demands.
Reacts to project adjustments promptly and efficiently.
Ability to bring projects from initiation to completion accurately.
Advanced in Microsoft Office applications including MS Word, Outlook, Excel, and PowerPoint.
Ability to communicate and work effectively, maintaining a courteous and professional demeanor, with patients and employees, at all levels of the organization.
Excellent customer service skills.

Naples Comprehensive Health - NCH

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