Institutional Review Board Coordinator

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

• 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.

CIP certification required to be obtained and maintained upon meeting eligibility criteria GCP certification required to obtained and maintained upon meeting edibility criteria.

• 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.

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.

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, religion, sex, sexual orientation, gender identify, national origin, disability, or protected veteran status.

Mercyhealth offers competitive pay and a comprehensive benefits package including:
Medical, Dental, Vision Life & Disability Insurance FSA/HSA Options Generous, accruing paid time off Paid Parental and caregiver leave Career advancement and educational opportunities Tuition and certification reimbursement Certification Reimbursement Well-being Programs Employee Discounts On-Demand Pay Financial Education Annual recognition/awards events Partner appreciation days Family entertainment/attractions discount Community service/improvement opportunities

At Mercyhealth, we don’t simply hire…