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Mgr, IRB - Institutional Review Board - Days

 

Mgr, IRB - Institutional Review Board - Days - Orlando Health Emergency Room and Medical Pavilion Osceola

Orlando health is seeking a Manager, InstitutionalReview Board. This candidate will beresponsible for the administration of Institutional Review Board (IRB) staffand operations, including the Board volunteers, establishing policies,procedures, priorities, schedules and quality standards.

Education Required

Bachelors Degree in Healthcare Administration, Business orrelated field required.

Experience

Four (4) years of related healthcare experience orequivalent.

Essential Functions

Responsible for department budget and financial reports.

Reviews protocols to ensure that the needs and requirements of PharmaceuticalSponsors remain within the regulatory guidelines of OH, National Institute ofHealth (NIH), Food and Drug Administration (FDA), and Office for Human ResearchProtections (OHRP).

Supervise the IRB Coordinator in the administrative support of the IRB.

Liaison between physicians, principal investigators, Corporate Office forResearch Operations (CORO) and the IRB

Effectively communicates new Institutional Review Board findings and continuingeducation to the physicians and Institutional Review Board by attending AppliedResearch Ethics National Association (ARENA) and Public Responsibility InMedicine &Research (PRIMR) conferences and keeping current with journals.

Maintains knowledge of Code of Federal Regulations pertaining to the FDA, NIHand OHRP.

Effectively manages formal federal agency audits and conducts IRB audits atclinical research sites investigating the compliance and safety of theirongoing trials.

Implement and maintain an Investigator Training program to ensure that PIs areeducated on current regulations, Good Clinical Practices, and overallresponsibilities in conducting of human subject research.

Facilitate the IRBs continuing education of the most current IRB issues andregulations.

Maintain IRB registration and federal-wide assurance as well as prepare the IRBfor future federal certification.

Administrator of ProIRB database system overseeing that updates are keptcurrent to ensure patient confidentiality.

Collaborates with various hospital departments and the hospital legal counselto meet all Orlando Health standards and State Laws.

Manages various human resources functions including hiring, work assignments,coaching plans, and performance counseling.

Maintains reasonably regular, punctual attendance consistent with OrlandoHealth policies, the ADA, FMLA and other federal, state and local standards.

Maintains compliance with all Orlando Health policies and procedures.

Other Related Functions

Knowledgeable and maintains theBoards compliance of the Belmont Report, International Congress ofHarmonizations Good Clinical Practices and the Declaration of Helsinki.

Responsible for facilitating aclose working relationship with the Institutional Review Boards physicianChairman and the Institutional Official, and CORO, to ensure consistent openlines of communication.

Ensures retention of curriculumvitae and other required records of all physicians, Principal Investigators,and Institutional Review Board members.

Participates as the IRBrepresentative for the Nursing Research Committee to provide regulatoryexpertise and to decipher which nursing research studies require further reviewby the IRB

Oversees the production anddistribution of approval letters and all other IRB documents.

Orients new principalinvestigators, physicians, and research staff about the Institutional ReviewBoard and its functions.

Responsible for keeping the CorpDirector for Research Regulation & Compliance current on viable IRB issues.

Licensure/Certification

Maintains current IRB Administrator certification -Certified IRB Professional (CIP) by the Public Responsibility in Medicine andResearch (PRIM&R).

Orlando Health is one of Floridas most comprehensive private, not-for-profit healthcare systems providing access to nearly two million Central Florida residents and has provided care for more than 4,600 international visitors annually. Our physician practices, diagnostic centers, hospitals and advanced medical treatments and procedures, along with our highly qualified team of medical specialists, have distinguished Orlando Health as a healthcare leader. We are one of Central Floridas largest employers with more than 15,000 employees and nearly 3,000 affiliated physicians supporting our philosophy of providing a continuum of care that revolves around patients needs. As a leading healthcare resource, providing world-class medical care as well as training our future healthcare providers, Orlando Health will continue to foster growth and development throughout the region for generations to come. We are looking for talented individuals to be part of our team.

QUALIFICATIONS:


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