The Corporate Office of Research Operations is responsible for oversight and management of Orlando Health’s research compliance and ensures compliance with applicable policies and external regulations. Our goal is to help facilitate research and to make sure it is done safely, ethically, and legally. We take pride in being service-oriented. The Orlando Health’s IRBs are charged with ensuring that all aspects of our Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence. This position, which is core to research compliance activities, focuses primarily on medical research.
We are seeking a candidate experienced with regulatory compliance and institutional review boards (IRBs) and that has excellent customer service skills.
In this position, under the direction of the Sr. Director Research Regulation & Compliance and the IRB Chair, you will conduct in-depth protocol review using advanced regulatory knowledge and experience. The primary responsibility will be to manage the protocol review process and identify issues, and to independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, and Orlando Health policies. You will also be involved in:
Developing, implementing, and managing efficient procedures to facilitate the processing of human protocols in accordance with local, federal, and state policies and procedures.
Performing review of complex research protocols, including identifying problems and issues in the submission application, and contacting the investigator orally or in writing to request additional materials.
Planning and coordinating IRB review and follow-up activities.
Serving as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Applying knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
Providing assistance to management in preparation for accreditation and in various compliance and quality assurance activities.
Occasional work on evenings and weekends or on-standard hours based on project or business needs.
This position has the potential to be a hybrid work role – a combination of onsite work and telecommuting – based on business and operational need.
Essential Functions
Developing, implementing, and managing efficient procedures to facilitate the processing of human protocols in accordance with local, federal, and state policies and procedures.
Performing review of complex research protocols, including identifying problems and issues in the submission application, and contacting the investigator orally or in writing to request additional materials.
Planning and coordinating IRB review and follow-up activities.
Serving as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Applying knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
Providing assistance to management in preparation for various compliance and quality assurance activities.
Occasional work on evenings and weekends or on-standard hours based on project or business needs.
Other Related Functions
Knowledgeable and maintains the Board’s compliance of the Belmont Report, International Congress of Harmonization’s Good Clinical Practices and the Declaration of Helsinki.
Responsible for facilitating a close working relationship with the Institutional Review Board’s physician Chairman and the Institutional Official, and CORO, to ensure consistent open lines of communication.
Ensures retention of curriculum vitae and other required records of all physicians, Principal Investigators, and Institutional Review Board members.
Participates as the IRB representative for the Nursing Research Committee to provide regulatory expertise and to decipher which nursing research studies require further review by the IRB
Oversees the production and distribution of approval letters and all other IRB documents.
Orients new principal investigators, physicians, and research staff about the Institutional Review Board and its functions.
Responsible for keeping the Senior Director for Research Regulation & Compliance current on viable IRB issues.
Orlando Health is a 3,200-bed system that includes 15 wholly-owned hospitals and emergency departments; rehabilitation services, cancer institutes, heart institutes, imaging and laboratory services, wound care centers, physician offices for adults and pediatrics, skilled nursing facilities, an in-patient behavioral health facility, home healthcare services in partnership with LHC Group, and urgent care centers in partnership with CareSpot Urgent Care. Nearly 4,200 physicians, representing more than 80 medical specialties and subspecialties have privileges across the Orlando Health system, which employs nearly 22,000 team members. Areas of clinical excellence are orthopedics, heart and vascular, cancer care, neurosciences, surgery, pediatric specialties, neonatology, women’s health and trauma.
Education/Training
Bachelor’s Degree in Healthcare Administration, Business or related field required.
Licensure/Certification
Maintains current IRB Administrator certification - Certified IRB Professional (CIP) by the Public Responsibility in Medicine and Research (PRIM&R) or equivalent certification.
Experience
Four (4) years of related healthcare experience or equivalent.
Orlando Health is a 3,200-bed system that includes 15 wholly-owned hospitals and emergency departments; rehabilitation services, cancer institutes, heart institutes, imaging and laboratory services, wound care centers, physician offices for adults and pediatrics, skilled nursing facilities, an in-patient behavioral health facility, home healthcare services in partnership with LHC Group, and urgent care centers in partnership with CareSpot Urgent Care. Nearly 4,200 physicians, representing more than 80 medical specialties and subspecialties have privileges across the Orlando Health system, which employs nearly 22,000 team members. Areas of clinical excellence are orthopedics, heart and vascular, cancer care, neurosciences, surgery, pediatric specialties, neonatology, women’s health and trauma.
