Institutional Review Board Coordinator
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- Grand Rapids, MI
- Mary Free Bed Rehabilitation Hospital
- Part-Time - Days - M-F, 8:00AM-5:00PM
- Posted: November 13, 2019
We have the great privilege of helping patients and families re-build their lives. It’s extraordinarily meaningful work and the reason we greet the day with optimism and anticipation. When patients “Ask for Mary,” they experience a culture that has been sculpted for more than a century. Our hallmark is to carefully listen to patients and innovatively serve them. This is true of every employee, from support staff and leadership, to clinicians and care providers.
Mary Free Bed is a not-for-profit, nationally accredited rehabilitation hospital serving thousands of children and adults each year through inpatient, outpatient, sub-acute rehabilitation, orthotics and prosthetics and home and community programs. With the most comprehensive rehabilitation services in Michigan and an exclusive focus on rehabilitation, Mary Free Bed physicians, nurses and therapists help our patients achieve outstanding clinical outcomes. The growing Mary Free Bed Network provides patients throughout the state with access to our unique standard of care.
Restoring hope and freedom through rehabilitation.
Diversity and Inclusion:
Mary Free Bed values diversity and inclusion among patients, families and staff. We strive to hire people who reflect the communities we serve. Our employees will serve all patients, families and each other with dignity and respect.
Responsible for overseeing the submissions for Human Research Protections program and Institutional Review Board processes.
Essential Job Responsibilities
- Assists research investigators and study coordinators in the processing of research proposals.
- Reviews and tracks new protocol submissions, amendments, adverse event reports, and progress reports. Ensures that protocols and associated documents submitted for IRB review are appropriate, complete and contain all the required elements to facilitate ethical review by the IRB. Notifies investigators about impending study expiration.
- Attends all Institutional Review Board (IRB) Meetings. Assists in the preparation and organization of the IRB meetings, agendas, minutes, and post meeting correspondence.
- Works harmoniously with the IRB Chair, IRB committee members, and investigators.
- Manages and maintains study files that document protocol activity.
- Participates in ongoing education and keeps current with federal regulations and state law; assumes primary responsibility to assure all IRB policies and procedures are compliant.
- Assists in development of new policies and procedures for the conduct of human subject research protections.
- Provides education and mentoring to investigators, research coordinators, IRB members and any other groups within the institution, as requested.
- Maintains training for responsible conduct for research and financial conflict of interest.
- Assists the Research and Innovation Department with special assignments upon request.
- May support the Quality Division with gathering and input of data to the UDS WeeFIM database to meet quarterly deadlines, as well as specialty clinical outcome reporting upon request.
Essential Job Qualifications (Knowledge, Education, and Training Requirements)
- Bachelor’s Degree in Allied Health, Health Science, or other relevant field.
- Certification as an IRB Professional (CIP), or commitment to training and sitting for certification examination within 2 years.
- Excellent written and verbal communication skills, and ability to lead and mentor others.
- Excellent organizational skills.
- Detail oriented with ability to prioritize and meet regulatory and timeliness requirements.
- Knowledge of medical terminology, medical coding, and outcomes databases.
- Computer skills, i.e. Microsoft Suite, databases, electronic submission, etc.
- Physical Demands:
- Able to exert up to 10-20 pounds of force occasionally (up to 1/3 of the time)
- Able to lift, carry, push, pull, up to 10-20 pounds occasionally
- Able to sit for the majority of the time, but may involve brief periods of time involving walking or standing.
- Able to use keyboard frequently (1/3 to 2/3 of the time)
Other Preferred Job Qualifications
- Experience in IRB administration, clinical research, or regulatory compliance with human subjects.
- Knowledge of the Common Rule (45 CFR46), FDA regulations, and other relevant requirements and guidelines related to the ethical study of human research subjects.