The Manager Institutional Review Boards (IRB) supports the Human Research Protection Office (HRPO) at Inova and the lnova IRBs to protect the rights and welfare of human research subjects. The Manager supervises IRB operations, including oversight and management of the HRPO regulatory team’s (IRB Analysts and Senior IRB Analysts) day-to-day activities in support of internal and external IRB reviews. The Manager will be responsible for ensuring comprehensive regulatory reviews of projects are conducted by the HRPO regulatory team in preparation for IRB review. The individual will oversee and ensure the accurate and timely processing, tracking, and filing of submissions related to human subject research.
He/she will communicate effectively with investigators, sponsors, IRB members, and external liaisons. The Manager will ensure the electronic research administration database contains accurate and comprehensive representations of reviewed research. The individual will ensure suspensions, administrative closures, and final reports are accurately represented in for the IRBs. The Manager triages the research portfolio submission inbox and assigns studies to the HRPO regulatory team for not-human-subject determinations, exempt, expedited or convened IRB review. The individual ensures investigators are aware of due dates for submission of renewals and other required reports.
The Manager also oversees the conduct of IRB meeting(s), assisting the HRPO regulatory team and IRB Chairs/Vice Chairs in ensuring regulatory requirements are considered and discussed during protocol reviews. The Manager confirms that the agenda is prepared and prioritized appropriately by the HRPO regulatory team and that the necessary review materials are provided to IRB members with sufficient review time before IRB meetings.
He/she will review meeting minutes to ensure all regulatory requirements are documented. The individual will provide regulatory guidance related to human subject research to the HRPO regulatory team, IRB members, and research stakeholders to ensure research is reviewed and conducted in compliance with institutional policies, State and federal regulations, ICH/GCP guidelines and HIPAA regulations. This list of duties and responsibilities is not intended to be aIIinclusive and may be expanded to include other duties or responsibilities as necessary.
Minimum Required Mininum 4-5 years of relevant experience. Three (3) years of previous IRB/HRPP experience required.
Preferred/Desired More than four (4 years) of IRB/HRPP experience required.
Education Degree in administrative, legal. or healthcare related field with experience in HRPP and IRB operations. Masters Degree in relevant field preferred Experience with research study design, protocol implementation and oversight of HRPP team members
Training Expert skills in overseeing and operationalizing HRPP and IRB operations. Experience with computerized research administration database administration, manipulation and analysis.
Minimum Ability to learn and implement New electronic submission management systems for IRB workspace
Special Skills Ability to work independently with minimal supervision and in a collaborative environment; Possess excellent written and oral communication skills; Knowledge of the applicable federal regulations related to human subject research, ICH/GCP and HIPAA. Ability to problem solve and manage a regulatory team.
Proficiency in Microsoft Office suite i.e. WORD, Excel, Powerpoint, etc.Previous electronic IRB submission system experience. Previous electronic IRB submission system experience.
Inova is a global leader in personalized health, which leverages precision medicine to predict, prevent and treat disease, enabling individuals to live longer, healthier lives. At Inova, we serve more than two million people each year from throughout the Washington, DC, metro area and beyond. Inova's mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. At Inova, more than 16,000 employees demonstrate their commitment every day to providing the community with expert, world-class, compassionate patient care.