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Naples Comprehensive Health - NCH · 19 hours ago

Coordinator Regulatory NCH Research Institute

Naples, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

Naples Comprehensive Health (NCH) is an independent, non-profit healthcare system delivering comprehensive care in Southwest Florida. The Coordinator Regulatory is responsible for managing regulatory documents for clinical trials, ensuring compliance with Good Clinical Practice (GCP), and facilitating communication between various stakeholders involved in the research process.

Health CareMedical

Responsibilities

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

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

Qualification

Regulatory complianceClinical trials managementClinical Practice (GCP)Microsoft OfficeCommunication skillsCustomer service skillsProblem-solving abilitiesTeam collaborationAttention to detail

Required

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

Company

Naples Comprehensive Health - NCH

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Naples Comprehensive Health (NCH) is an Advanced Community Healthcare System™ in Naples, Florida, serving Southwest Florida with premier routine, critical, and specialty care.

Founded in 1953

Naples, Florida, USA

1001-5000 employees