Institutional Review Board Coordinator

Do you have a passion for healthcare and helping others? Do you enjoy working in a fast-paced, patient-centered environment? Jump-start your career in our Review Board department. Submit your application today.

Benefits:

We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program. We would love to talk to you about this fantastic opportunity.

Seeking a Institutional Review Board (IRB) Coordinator to join our team who under the direction of the Methodist Healthcare System Institutional Review Board (IRB) Director, will coordinate complex and broad administrative matters for the IRB. Assists in the identification of potential regulatory issues with human subject research protocols, provides technical support and procedural guidance to regulatory or compliance staff, investigators and the IRB.

What you will do in this role:

• Performs timely initial detailed review of IRB applications to determine completeness, including analysis of protocols & supporting documents, and review of Informed Consent Forms (ICF) for regulatory compliance and conformance with institution’s requirements & ethical standards. Assigns applications to appropriate review category; administrative, exempt, expedited, or full board. Solicits and perform initial reviews of human research protocol renewal applications in a timely and efficient manner, and assigns to designated expedited reviewer, or full board as appropriate.
• Coordinates and attends IRB meetings. The IRB Coordinator will notify IRB members of the meeting date, time and location, distribute agendas/minutes and any accompanying documentation to members; and contact Principal Investigators (PI) /research personnel or other departments for information requested by the IRB. Records meeting minutes, documenting medical & ethical issues discussed, and the final committee determinations. Composes clear, concise and detailed correspondence to PI to ensure that committee concerns, questions and rationale are appropriately communicated to researchers. Evaluates and reviews with IRB Chairperson or designee the investigator’s responses to determine if they are adequate or if additional information is needed.
• Acts as liaison between the IRB and investigators providing advice and technical assistance regarding the IRB application process, consent form preparation, and other issues related to IRB review and approval. Provides day-to-day administrative coordination & correspondence between investigators, IRB Chairperson, IRB Director, research staff and research reviewers.
• Maintains a current understanding of Federal, State and Institutional regulations and guidelines governing human subject research . Assists the IRB Director in the development of regulatory compliance policies and procedures, training/education materials (including website updates). Participates in Human Subject Protection Program quality assurance activities, providing consultation, presentations, and training on human research ethics and IRB policies & procedures to departments and other interested groups.
• Maintains accurate IRB files/records and IRB Access database, ensuring strictest confidentiality compliance on all IRB and MHS matters/records according to HIPAA, HHS, and FDA regulations, and state laws. Conducts ongoing audit of IRB of all IRB files and filing systems for quality assurance purposes. Reviews incoming submissions and updates database files as needed.
• Oversees and assists with the IRB’s electronic document submissions program training. Maintains Human Subjects Protection training records and audits incoming submissions to verify training is up to date for all identified key personnel.

• Bachelor’s degree in related field