Hello, we just posted a position for an IRB Coordinator for our rural 7 hospital health system in Michigan.
POSITION SUMMARY
The IRB Coordinator will serve as a contact and resource for investigators, faculty, and staff at Munson Healthcare and partner organizations. The position provides technical and administrative coordination to help facilitate the review of research protocols involving human subjects. This position provides education and retains documentation of training as regulated federally and by standing Munson Healthcare policies. The IRB Coordinator facilitates the research review and approval process of biomedical, social, and behavioral research and maintains records for all research submitted and processed by the Munson Healthcare IRB. An extensive understanding of human subject research regulations and federal guidance documents is critical. Work is completed in accordance with the processes and procedures that ensure compliance with federal and state laws, regulations, institutional policies, and guidelines governing human research protections.
ENTRY REQUIREMENTS
Bachelor's Degree in biomedical, health science, social science or related field is required,
Master's Degree in a health care or regulatory related field preferred.
Certification as an IRB Professional (CIP) preferred and expected within two years.
A minimum of 2-4 years of experience directly related to human subject research or 2-4 years of experience in a related area required. Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects, including 45 CFR 46 and 21 CFR 50, 56, 312 and 812.
Demonstrated analytical skills to gather, interpret, organize, and present compliance related data.
Demonstrated success working collaboratively with interdisciplinary teams of external and internal individuals.
Well organized, high energy, effective at multi-tasking, self-motivated and detail oriented.
Strong interpersonal and communication skills.
Demonstrates competency in the use of a variety of computer programs, including Microsoft products, electronic data entry systems like IRBnet.
Ability to work effectively and efficiently under tight deadlines, high volumes, and multiple interruptions.ORGANIZATION
Reports to Director of Research and Sponsored Programs. Works closely with IRB members, IRB Chair, research teams, physicians, and medical students.
POPULATIONS SERVED COMPETENCIES, INCLUDING AGE OF PATIENTS SERVED
No direct clinical contact with patients
ESSENTIAL DUTIES AND RESPONSIBILITIES
Supports the Mission, Vision and Values of Munson Healthcare.
Embraces and supports the Performance Improvement philosophy of Munson Healthcare.
Promotes personal and patient safety.
Uses effective customer service/interpersonal skills at all times.
Supports IRB operation to protect the rights and welfare of human research subjects per the federal code of regulations and good clinical practice guidelines.
Responsible for all activities in support of the Institutional Review Board by facilitating and participating in the regulatory review of human subject's research conducted at Munson Healthcare.
Provides regulatory support and oversight for the Research Community and serves as a point of contact for submission inquiries and requests for guidance and consultation as it pertains to the federal regulations, state and local laws, as well as Munson Healthcare Policies governing human subject's research.
Ensures that Munson Healthcare's human research activities are conducted in compliance with institutional standard operating procedures (SOPs) and international, federal, state, and local rules and regulations and ethical principles regarding human subject research.
Works in collaboration with the Institutional Review Board (IRB) Committee and may serve as a "designated" reviewer, as applicable.
Assists and guides investigators through the application submission process.
Prepare and arrange for the research approval activities related to the operation of the IRB throughout the review process.
Responsible for processing and preparing research protocols and related actions in advance of initial and continuing reviews by the IRB. Creating meeting agendas, preparing reports and corresponding with investigators throughout the post review process. Interprets and advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements. Functions as a liaison within and between the IRB committee, investigators and their designees, and other research support staff.
Ensures timely processing, review and disposition of research applications within established expectations and SOPs.
Responsible for maintaining the security and integrity of federally and contractually mandated regulatory data assuring comprehensive and compliant IRB documentation and records in accordance with regulations and SOPs.
Responsible for the maintenance and retention of all required IRB records, communications, and other files for assigned submissions. Possesses a comprehensive and broad understanding and knowledge of federal and state regulations, state and local law and IRB SOPs. Develops SOPs and policies for the IRB and Munson Healthcare to include topics such as IRB Operations,
Overarching special topic guidance sheets, HIPAA in relation to research and Conflicts of Interest in research. Assists with the conduct of IRB Post Approval Monitoring activities as required by federal regulations and local SOPs.
Develops and implements effective IRB educational strategies.
Performs other duties as assigned.
Please reach out to me with any questions and please share! This is a hybrid remote position but the individual must be available to come into the office in Traverse City when needed-so entirely remote is not an option.
Apply online at :
Munson Healthcare Careers - Institutional Review Board IRB Coordinator - Hybrid Remote (jobvite.com)------------------------------
Amy Peterson
Director, Research and Sponsored Programs
Munson Healthcare
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