Senior IRB Specialist - Research Administration - Orlando FT

Senior IRB Specialist – Research Administration – Orlando

Location Address:  601 E. Rollins St., Orlando, FL 32801

Top Reasons to work at AdventHealth Orlando

• 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

Work Hours/Shift:

•  Full Time, Days

You Will Be Responsible For:  

The Senior IRB Specialist exercises objective and independent judgement to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations while working collaboratively with the IRB Manager, staff and IRB Chair. The Senior IRB Specialist is knowledgeable in the areas of state and federal laws and regulations, ethical issues, institutional policies, and other agency requirements which govern the protection of human subjects in research. The Sr IRB 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 Sr IRB 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.

What You Will Need:

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelor’s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field and five (5) years of IRB or research related experience preferably in an academic or medical setting; OR
• Associates degree in legal studies, healthcare, business administration, finance, accounting, or research-related field and seven (7) years of IRB or research related experience preferably in an academic or medical setting; OR
• Equivalent work consisting of at least eight (8) years of IRB or research related experience preferably in an academic or medical setting

EDUCATION AND EXPERIENCE PREFERRED:

• • Master’s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field
  • Five (5) years of IRB or research related experience preferably in an academic or medical setting.

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

• Certified Institutional Review Board Professional

KNOWLEDGE AND SKILLS PREFERRED:

• • Knowledge of AdventHealth policies and procedures related to human subject research and research administration
  • Working knowledge of IRB related database software applications

Job Summary:

• In coordination with the IRB Manager, orients, trains, provides guidance to new staff as well as to achieve departmental goals and objectives.
• Reads and interprets current regulations, guidelines, and trends influencing the conduct of human subject research.
• Serves as a subject matter expert across the AdventHealth System on matters pertaining to human subject research.
• Interacts with all levels of management and staff to provide useful information, guidance, and integrity to human subject research activities

• Has responsibility to act as acting IRB manager in the manager’s absence. 
• 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.

• Develop and conduct educational classes’ specific to human subject research to both researchers and IRB members.
• Counsels investigators and support staff in resolving IRB committee contingencies.
• Serves as an IRB voting member.  Attend committee meetings and serve as a resource on human subject research regulations and institutional requirements for committee members and Chairs.
• Serve as the lead for training on the IRB electronic submission system. Provide guidance to research coordinators and investigators regarding applications in preparation for submission to FH IRB.
• Interacts directly with IRB manager, IRB Chair, IRB members, physician researchers, other researchers and study teams on a daily basis to facilitate the research review process.
• Exercises objective and independent review to makes decisions on level of review and assigns reviews to IRB members
• Applies applicable regulations and make decisions on whether submissions can be approved, when not submitted for convened board review. Includes new studies, modifications, annual renewals. 
• Manages process that controls when studies can be reviewed by external IRBs.
• Works closely with the research regulatory core team to ensure information provided to the IRB within application forms and other documents is consistent and complete.
• Develops, updates and communicates policies and procedures in research administration.