Institutional Review Board Coordinator - Full Time

Overview

The IRB Coordinator provides regulatory expertise, guidance and administrative support to the Institutional Review Board reviewing human subject research protocols.

The IRB Coordinator serves as the primary regulatory resource for investigators and staff Locations: Hybrid schedule with ability to visit Mercyhealth locations Schedule : Monday-Friday, 40 hours/week Shift : Days Essential Duties and Responsibilities Serve as subject-matter expert by educating, consulting and guiding researchers and staff in the design and conduct of human subject research to ensure compliance with federal and state regulations and Mercyhealth policy and standard operating procedures (SOPs) Provides guidance for research investigators and research staff regarding procedural requirements in the processing of research proposals Reviews new research applications for consistency, completeness and compliance with federal and state regulations and institutional guidelines Review documents for protocol and amendment-specific content and to ensure presence of federally mandated elements of informed consent.

Communicate to Principal Investigators items that require clarification or documents required for submission, to complete a research application Provide written correspondence that accurately documents the determinations of the IRB and describe any revisions required by the research team Evaluate reports of unanticipated problems, noncompliance, amendments and continuing review forms and prepare recommendations to the committee Educate and guide IRB members on the federal and state regulations and Mercyhealth policies and SOPs governing human subject research Assist in developing, recommending and implementing policies and procedures Monitor regulatory environment and recommend changes, as needed to IRB Prepare agenda, meeting materials, and minutes and maintain accurate files related to the IRB Education and Experience Bachelor's degree in biomedical, health science, social sciences or related field is required.

Experience in healthcare or directly related to human subject research is required. Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects is required. Moderate level of experience using Microsoft Office products is required Certification and Licensure CIP certification required to be obtained and maintained upon meeting eligibility criteria GCP certification required to obtained and maintained upon meeting edibility criteria. Skills and Abilities Ability to interpret and apply laws and regulations Excellent written and verbal skills Attention to detail and extensive organization skills.

Excellent problem solving, reasoning and critical thinking skills Excellent typing and word processing skills. Excellent knowledge of spreadsheet and database software Position responsibilities require a high level of independent judgment and has latitude for independent action. Special Physical Demands The…

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