AdventHealth Orlando seeks to hire a Operations Specialist - IRB who will embrace our mission to extend the healing ministry of Christ.
Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando, serves as the major tertiary facility for much of the Southeast, the Caribbean and South America. AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country. We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year.
The Operations Specialist - IRB works collaboratively with the IRB Manager, staff and IRB Chair to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations. The Operations Specialist conducts quality control functions for the IRB office that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency. The position works to identify gaps and works directly with the IRB manager to develop policies and procedures. The Operations Specialist takes on the lead for training IRB Office Coordinators, external IRB review processes, IRB electronic submission process and special projects as requested. Actively participates in outstanding customer service and accepts responsibility for maintaining relationships that are equally respectful to all.
Working knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other agency requirements which govern the protection of human subjects in research (45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report )
Excellent written and verbal communication skills
General medical knowledge and familiarity with the conduct of research
Organized and detail oriented
Ability to handle several tasks/projects at a time, prioritize responsibilities, and work under deadline pressures
Comfortable and able to work within an electronic environment
Ability to function independently in terms of decision-making and meeting job requirements
Cooperative and positive attitude
Working knowledge of database software applications (Preferred)
Five years IRB or research-related work experience
Bachelor's degree in business, healthcare, or related field experience (Preferred)
Four years IRB or research- related work experience (Preferred)
Licensure, Certification, or Registration Required:
Certified Institutional Review Board Professional (Preferred)
Demonstrates through behavior AdventHealth's Core Values of Keep Me Safe, Love Me, Make it Easy, and Own it as outlined in the organization's Performance Excellence Program.
Research, draft, review and assist with developing new procedures and changes to existing procedures.
Monitor, review, and report on performance measures. Audit and monitor studies and consent process.
Conduct educational classes' specific to human subject research. Provide educational and directive responses to general human subject questions from AH investigators and research staff.
Serve as the lead for training IRB Office Coordinators and the IRB electronic submission system. Provide guidance to research coordinators and investigators regarding applications in preparation for submission to AH IRB.
Counsel investigators and support staff in resolving committee contingencies. Once submitted, review responses from investigators and approve protocols (when compliant). Maintain working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research
Process incoming IRB submissions. Monitor external IRB review process.
Serves as an IRB member. Attend committee meetings and serve as a resource on human subject research regulations and institutional requirements for committee members and Chairs.
Interact directly with IRB manager, IRB Chair, IRB members, physician researchers, study teams on a daily basis to facilitate the research review process.
May assist with developing Research Matters meeting content and presentation. May have responsibility to act as manager in the manager's absence. May assist with preparations for the AH IRB Annual Conference. Performs other duties as assigned.
If you want to be a part of a team that is dedicated to delivering the highest quality in patient care, we invite you to explore the Operations Specialist - IRB opportunity with AdventHealth Orlando and apply online today.
AdventHealth Greater Orlando (formerly Florida Hospital) is one of the largest faith-based health care providers in the United States. For 150 years, we have carried on a tradition of providing whole-person care that not only addresses patients' physical ailments, but also supports their emotional and spiritual well-being. We demonstrate the same level of compassion and care for our employees as well, doing all that we can to help them realize their full potential – both personally and professionally.