Senior Research Subject Protection Specialist
Provides complex administrative support within the Office of Research Subject Protection (ORSP); performs a variety of detailoriented preparation and processing of materials related to the Institutional Review Board (IRB). Pre-review materials in preparation for IRB review, has interaction with investigators, research staff and committee members, and assures submissions are processed and reviewed in a manner consistent with federal and state laws and regulations and Institute policies. Coordinates the review and processing of protocols encompassing all types of human subject research, amendments and continuing reviews of IRB submissions and advises investigators and research staff on processes, issues and status related to these applications. Reviews materials returned by investigators for completeness and inclusion of required changes within limited time frames. Provides guidance to research staff, investigators, and IRB members regarding Federal regulations, FDA requirements and IRB policies and procedures. Assists in assigning and administering the IRB committees for review of studies and notification of the Principal Investigator and research staff on the outcome of the IRB review. Coordinates and supports committee meetings, including scheduling, preparing minutes and assisting during the meeting, as well as required filings with various agencies overseeing research. Assists with IRB accreditation and maintaining standards for the IRB. Maintains established departmental policies and procedures, objectives, quality assurance programs, safety and compliance standards.
Applicants must possess a Current certification as a Certified IRB Manager (CIM) by the National Association of IRB Managers (NAIM); or a Current certification as a Certified IRB Professional (CIP) by the Public Responsibility in Medicine and Research’s (PRIM&R) Council for Certification of IRB Professionals (CCIP); or a Current certification as a Certified Professional IACUC Administrator (CPIA) by the Public Responsibility in Medicine and Research’s (PRIM&R) Council for Certified Professional IACUC Administrators (CCPIA). As well as a Bachelor’s degree and the equivalent of two years of full-time experience in IRB or IACUC processing; or an Associate’s degree and the equivalent of four years of full-time experience in IRB or IACUC processing; or a High School Diploma or High School Equivalency Diploma and the equivalent of six years of full-time experience in IRB or IACUC processing. The preferred candidate will possess certification as an IRB professional (CIM or CIP), Bachelor's degree, and at least two years experience in IRB processing of human subject research. The preferred candidate will have knowledge of federal regulations and IRB requirements governing human subject research. The preferred candidate will also possess advanced computer skills in order to work with and maintain electronic submission and review systems and databases. The preferred candidate will also be detail-oriented, able to carry out routine duties and problem solve with minimal supervision, have the ability to work within standard operating procedures, able to understand medical and technical information and apply prescribed criteria, and have excellent communication, organizational, and time management skills.
This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.
Health Research Incorporated (HRI) Roswell Park Division participates in the E-Verify program.
Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans