IRB/HRPP Coordinator
Core
Ensures continuity and consistency of the research proposal process and facilitates the protocol process from submission to completion within the Human Research Protections Program.
Role type
HRPP Regulatory Compliance Analyst
Builds
Ethical and compliant human research protocols and committee meeting materials
Domain
Healthcare research compliance and regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance analysis, proposal processing, committee meeting facilitation, policy application, quality audit execution, training delivery, database verification
Preferred skills
biosafety and radiation review coordination, single IRB submission processing, strategic plan development, preceptorship
Technologies
None explicitly stated
Responsibilities
Prepares, analyzes, reviews, and processes new research proposals, amendments, adverse events, and continuing review applications; Analyzes proposal submissions for coordination of biosafety and/or radiation review; Processes Single IRB submissions; Applies HRPP policy and federal regulations to proposed research; Prepares for and facilitates committee meetings by creating and pre-reviewing agenda templates and meeting materials; Completes and distributes Committee Action Letters and Final Approval Letters; Manages Continuing Review notification(s) prior to expiration date of protocol; Performs oversight and verification of database entries; Routinely initiates and performs quality audits; Assists with development and revision of existing policies and procedures; Serves as a preceptor to new staff; Prepares and provides training and acts as internal consultant to staff; Provides customer service to the research community regarding navigation of research regulations and the IRB submission process
Seniority
Mid-level, hands-on IC