Senior IRB Specialist - Research Administration - Maitland
Full Time, Days
You Will Be Responsible For:
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.
What You Will Need:
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
Knowledge of the conduct of human subject research.
Motivated, organized and able to function independently
Excellent interpersonal skills and a collaborative style necessary for interaction across departments.
Advanced written and verbal communication skills with demonstrated proficiency for current spelling, grammar, tone, and syntax
Proficient in MS Office Suite (Outlook, Word, Excel, Publisher, PowerPoint, etc.), internet, and other research tools, word-processing and databases
Ethical and diplomatic with an ability to provide excellent customer service.
Ability to work under pressure, meet fixed deadlines, and manage competing priorities
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.
Knowledge of AdventHealth policies and procedures related to human subject research and research administration
Working knowledge of IRB related database software applications
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.
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.
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.