Research Subject Protection Specialist
Provides complex administrative and clerical support within the Office of Research Subject Protection (ORSP); performs a variety of detail-oriented preparation and processing of materials related to the Institutional Review Board (IRB). Pre-reviews 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 assigned protocols, 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. Supports committee meetings, including scheduling, preparing minutes and assisting during the meeting.
Applicants must possess a Bachelor’s degree in an appropriate field; or an Associate’s degree in an appropriate field and the equivalent of two years of full-time experience in IRB or IACUC processing; or a High School Diploma or High School Equivalency Diploma and the equivalent of four years of full-time experience in IRB or IACUC processing. The preferred candidate will possess a Bachelor's degree and at least one year experience in clinical research, or in a health or regulatory-related field. The preferred candidate will have knowledge of federal and state 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 be detail-oriented, able to carry out routine duties with minimal supervision, able to understand medical and technical information and apply prescribed criteria, have the ability to work within standard operating procedures, 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