A critical member of the Human Research Protection Program (HRPP) Office within the Protocol Activation and HRPP Unit in Clinical Research Administration (CRA) , this position provides operational, technical, administrative leadership and expertise in Institutional Review Board/Privacy Board review committee management and oversight to support the achievement of Center goals for Time to Activation and most importantly to ensure the rights and welfare of MSK's research participants are protected. This position is a leader charged with the operational oversight and management of the IRB/PB, and must ensure full compliance with Institutional, State and Federal regulations (i.e. FDA, Office of Human Research Protections, Office of Civil Rights) and guidances regarding human subjects' protection, AAHRPP(Association for the Accreditation of Human Research Protection Programs) requirements, and others as needed.
Lead the IRB/PB administration teamon the day-to-day operational activities as they relate to the IRB/PB Committee meetings.
Manage the IRB agenda including organizing and finalizing that requires utilizing critical thinking and working knowledge of regulations ensure content is aligned with federal regulations and IRB/PB SOPs.
Co-manage the IRB administration staff (e.g. IRB Analysts, Coordinators) with the other IRB/PB Administrator.
Facilitate IRB/PB Meeting with Chair and/or Co-Chairs, documenting all discussions and actions in accordance with regulations and IRB/PB SOPs.
Write and ensure completion of communications (actions, determination letters-outcomes) in the specified turnaround time.
Provide regulatory guidance to MSK Investigators and clinical research (CR) staff.
Review non-compliance reporting and oversees the real-time management of IRB submissions that must be processed immediately due to patient care needs (e.g., Emergency/Compassionate Use, Prospective Deviations).
Define metrics for determining progress/success. Provides specialized queries, reports and graphical presentations to leadership.
Train IRB/PB members, clinical research teams and HRPP staff, as required.
A Bachelors degree with at least 4 years of clinical research/ human subjects protection experience or equivalent experience, Masters preferred.
Experience in staff supervision and management preferred.
Previous HSP/IRB experience in oncology setting highly preferred.
Certified IRB Professional (CIP) expected after a minimum of one year in the job based on certification requirements and years of prior IRB experience.
Federal Regulations: Must have an advanced comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
Administrative Skills: Excellent administrative skills. Detail-oriented with the ability to multi-task and prioritize workload. Good organizational skills needed.
Communication Skills: Excellent communication skills both oral (for presentations and with contacts) and written (e.g., letters, memorandums). Ability to interact with a diverse group of individuals (e.g., physician leaders, investigators, Committee Chairmen, research management and research support staff).
Analytical Skills: Ability to analyze and draw conclusions from information received and to be able to convey the information to others. Ability to comprehend and apply regulations and SOPs to information presented for consideration by the IRB. Ability to exercise independent judgment and discretion and trouble-shoot without much direction. Excellent problem-solving ability.
Computer Skills: Excellent computer skills. Proficient in Microsoft Office programs (Word, Excel, Access, and Outlook) and relational databases. Familiarity with Adobe software and Crystal Reports. #LI-POST
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