Remote IRB Manager | Corp Research Operations | Full Time bei Orlando Health

Orlando Health Corporate

Department: Institutional Review Board    

Shift: Day | FT

Location: Corp 1414 Kuhl Ave Orlando FL 32806     

Title: Institutional Review Board Manager  

Summary: Overall responsibility for management and administration of Institutional Review Board (IRB) staff and operations, including the Board volunteers, establishing policies, procedures, priorities, schedules and quality standards.

Forbes has named Orlando Health as one of America's Best-In-State Employers. Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible, so that you can be present for your passions.

“Orlando Health Is Your Best Place to Work” is not just something we say, it’s our promise to you.”

Orlando Health proudly embraces and honors the individuality of our team members. By sharing different ideas and perspectives and working together as a team, we are better able to relate to, care for and authentically serve our patients and families who make up the collective populations in our community. So, no matter who you are, what you believe or how you express yourself, you are welcome here.

ORLANDO HEALTH - BENEFITS & PERKS:

Competitive Pay

• Evening, nights, and weekend shift differentials offered for qualifying positions.

All Inclusive Benefits (start day one)

• Student loan repayment, tuition reimbursement, FREE college education programs, retirement savings, paid paternity leave, fertility benefits, back up elder and childcare, pet insurance, PTO/Holidays, and more for full time and part time employees.

Forbes Recognizes Orlando Health as a Best-In-State Employer

• Forbes has named Orlando Health as one of America's Best-In-State Employers for 2021. Orlando Health is the top healthcare organization in the Metro Orlando area to make the prestigious list. "We are proud to be named once again as a best place to work," said Karen Frenier, VP (HR). "This achievement reflects our positive culture and efforts to ensure that all team members feel respected, supported and valued.

Employee-centric

• Orlando Health has been selected as one of the “Best Places to Work in Healthcare” by Modern Healthcare.

Essential Functions
 Responsible for department budget and financial reports.
 Reviews protocols to ensure that the needs and requirements of Pharmaceutical Sponsors remain within the regulatory guidelines of OH, National Institute of Health (NIH), Food and Drug Administration (FDA), and Office for Human Research Protections (OHRP).
 Supervise the IRB Coordinator in the administrative support of the IRB.
 Liaison between physicians, principal investigators, Corporate Office for Research Operations (CORO) and the IRB
 Effectively communicates new Institutional Review Board findings and continuing education to the physicians and Institutional Review Board by attending Applied Research Ethics National Association (ARENA) and Public Responsibility In Medicine & Research
(PRIMR) conferences and keeping current with journals.
 Maintains knowledge of Code of Federal Regulations pertaining to the FDA, NIH and OHRP.
 Effectively manages formal federal agency audits and conducts IRB audits at clinical research sites investigating the compliance and safety of their ongoing trials.
 Implement and maintain an Investigator Training program to ensure that PIs are educated on current regulations, Good Clinical Practices, and overall responsibilities in conducting of human subject research.
 Facilitate the IRB’s continuing education of the most current IRB issues and regulations.
 Maintain IRB registration and federal-wide assurance as well as prepare the IRB for future federal certification.
 Administrator of ProIRB database system overseeing that updates are kept current to ensure patient confidentiality.
 Collaborates with various hospital departments and the hospital legal counsel to 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 Orlando Health 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 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 Corp Director for Research Regulation & Compliance current on viable IRB issues.                                                                        

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).

Experience
Four (4) years of related healthcare experience or equivalent.