Institutional Review Board Coordinator

Position: 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 IRBPrepare agenda, meeting materials, and minutes and maintain accurate files related to the IRBEducation 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 LicensureCIP certification required to be obtained and maintained upon meeting eligibility criteriaGCP 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 Special Physical Demands are considered Essential Job Functions of the position with or without reasonable accommodations.

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.

Level of Supervision Performs under the Manager of Research, Ethics and Chaplaincy.

Supervises This position has no supervisory responsibilities.

PAY RANGE:$54,319.95 - $84,195.93

Mercyhealth is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color,…