Institutional Review Board (IRB) Coordinator 20 hours/week

Baptist Health Deaconess Madisonville•Madisonville, KY

21h•Onsite

About The Position

This position involves coordinating the activities of the Institutional Review Board (IRB), ensuring compliance with federal guidelines, and supporting the IRB chair and members. The role requires meticulous record-keeping, communication with investigators, and participation in quality improvement initiatives. The IRB Coordinator will manage all aspects of investigational protocol submissions, meeting preparation, and file maintenance.

Requirements

Experience in reviewing investigational protocol submissions.
Ability to draft meeting agendas and take thorough minutes.
Proficiency in assisting investigators and CRCs with form completion.
Skill in preparing and distributing meeting packets.
Experience in maintaining study tracking systems and ensuring follow-through.
Knowledge of FDA file requirements and auditing for compliance.
Ability to process incoming mail and determine appropriate actions.
Experience in maintaining and updating policies and procedures.
Ability to coordinate complaint resolution processes.
Skill in referring calls and resolving issues as directed.
Experience in maintaining IRB member rosters and tracking attendance.
Familiarity with maintaining Emergency Department and on-call schedules.
Experience in maintaining medical staff and allied health staff credentials and OPPE files.
Ability to track and document expirable documents for medical and allied health staff.
Proficiency in purging and archiving inactive files.
Willingness to perform other duties as assigned.
Experience with new provider orientations.
Ability to respond to affiliation verification requests.
Experience in processing credentials files and audits.
Assistance with coordination of Ethics Committee consultations.

Responsibilities

Reviews all new investigational protocol submissions and assigns them to committee members as directed by the Institutional Review Board chair.
Drafts agendas for IRB meetings.
Assists investigators and Clinical Research Coordinators (CRCs) with the completion of appropriate forms.
Prepares and distributes Institutional Review Board Meeting packets for IRB members.
Attends IRB meetings and takes thorough minutes.
Prepares drafts of letters to Investigators regarding the results of proposed studies.
Ensures a tracking system is in place for all studies and that timely reminders and follow-through by the committee occur.
Maintains files as required to meet FDA requirements.
Audits files routinely for compliance.
Reviews and processes all incoming mail to determine appropriate actions.
Maintains current policies and procedures for the Institutional Review Board, ensuring annual review and update at a minimum.
Coordinates the complaint resolution process.
Refers appropriate subject calls to the Institutional Review Board Chairperson.
Works with individuals to resolve issues as requested by the Institutional Review Board Chairperson.
Maintains policy regarding complaint resolution.
Participates in Quality Improvement activities.
Documents outcomes and recommends processes for improvement.
Maintains IRB member roster and tracks attendance to ensure compliance with federal guidelines.
Maintains monthly Emergency Department and Daily on-call schedules.
Maintains medical staff and allied health staff credentials and OPPE files.
Tracks and documents medical staff and allied health practitioner staff expirable documents, including follow-up contact with individuals to obtain copies of appropriate licensure, DEA, certifications, health testing, and certificate of malpractice insurance coverage.
Purges and archives inactive medical staff and allied health practitioner staff credentials files for offsite storage.
Performs other duties as assigned in the Medical Staff Resources Department, including but not limited to coverage of the office, assisting with new provider orientations, responding to affiliation verification requests, and assisting with processing of credentials files and audits.
Assists with coordination of Ethics Committee consultations.