This is a full-time position. The NYSPI Protocol Navigator will assist investigators conducting human research with the complexities of developing research protocols and adhering to applicable regulatory and institutional requirements and ethical standards.
This is a hybrid role with 50% on-site requirement in NYC.
Duties and Responsibilities:
The Protocol Navigator will assist in the creation and pre-review of human research protocols and related documents, ensuring accuracy, consistency, and completeness. This includes, but is not limited to, conducting a congruency review of the grant and study protocol, where applicable. The Protocol Navigator will steer and assist investigators in the submission of protocols to an external Institutional Review Board (IRB) under a reliance process, including initial submissions, amendments, reportable events, and continuing reviews. Serving as a primary point of contact for investigators and research staff, the Protocol Navigator will address inquiries submitted to the HRPP mailbox, assist with weekly HRPP office hours, and provide regulatory and ethical guidance when needed. The Protocol Navigator will also work to ensure that all research activities are conducted in accordance with NYSPI policies, guidelines, and all relevant regulatory requirements. The Protocol Navigator will assist in comprehensive record keeping and development of internal systems for tracking and managing the work of the NYSPI IRB Office. Other duties as assigned.
Minimum Qualifications:
Completed 4-year degree and 5 years of experience in an IRB or Human Research Protection Office or with the conduct of human research.