Position Highlights: Position: IRB Coordinator Location: 1001 University Place - Research Travel: Full Time/Part Time: Full-time Hours: 8:00 am-5:00 pm, on site, hybrid not available What you will need: Education: Bachelor's Degree Experience: Research experience in clinical tials preferred. Minimum of 2 years of progressive experience in clinical research administration. Knowledge of federal regulationss and rules for human subject protection. Good verbal and written communication skills. What you will do: Corporate Expectations NorthShore University HealthSystem Research Guidelines Institutional Review Board (IRB) policies and informed consent regulations Collaborate with investigator and sponsor/CRO to prepare IRB submissions, consent forms and revisions Local, State, and Federal research regulations Protocol initiation with Principal Investigations, Sponsors, and Research Coordinators Submission of research applications, revisions, modifications, amendments, and periodic progress... reports Maintains documentation of Investigator and Staff Qualifications Maintains current vitae, license, certifications for investigators and study personnel Provides the study sponsor, IRB and others as needed with documentation of credentials Demonstrates the proper education, trainingand experience of staff to conduct the clinical investigation Facilitates the conduct of the clinical investigation by providing form FDA 1572 and other regulatory documents for signature Maintains documentation related to disclosing conflicts of interest as described in the regulations Facilitates Initial and Ongoing Review by a Duly Constituted IRB Provides the IRB with adequate information to initially review the study (i.e., protocol, investigator's brochure, informed consent Provides the IRB with documents for continuing review (i.e., amendments to the protocol, adverse events deviations Obtains written IRB aprova prior to initiating the study or instituting any changes to the protocol. Communicate approval to Principal Investigator, Sponsor/CRO and others as needed. Provides written summaries of the trial status to the Administrative Director, IRB or others as requested Provides written information of premature study termination or suspension of a trial to the Principal Investigator, IRB Sponsor/CRO and others as needed Assures the Proper Storage of Investigational Articles Arranges proper shipment and delivery of the investigational article (e.g. Pharmacy, Principal Investigator) Assures that the proper storage conditions for the investigational article are available and employed Provides a correctly dated and approved informed consent for each study Coordinates with Pharmacy (if applicable) to notify the Principal Investigator or designee of delivery of an investigational artical Verifies that delivery of an investigational article is correct and documented Prepares regulatory documents for sponsor/audit review Prepares for and participates in federal agency inspections as needed Assures that study records are prepared, documented and shipped for long term storage. Retrieve documents as needed for monitoring or audit. Protects the Rights ad Welfare and Research Subjects Collaborates with Principal Investigator to submit reports of adverse events to the sponsor and IRB according to regulations nd NorthShore University HealthSystem policies. Assures that the informed consent documents contain all the required and appropriate additional elements required by 21 CFR 50, 45 CFR 46 and the IRB Assures that the HIPAA document contains all the required appropriate elements. Collaborates with Principal Investigator/Sponsor/CRO to revise consent documents as required by regulation, IRB or NorthShore University HealthSystem policy Monitors and ensures that toxicity and adverse events are reported to appropriate entities. Implementation, Maintenance, and Evaluation of Research Protocol Demonstrates ability to accurately describe designated research protocols Practices as part of research team and assists other research staff as needed Demonstrates ability to assist with implementation of protocols, data submittal, development of patient calendar Maintains communication with Principal Investigator or designee throughout designated studies Assists Administrative Director to provide education, counsel and resources for protocol compliance in cooperation with nursing Assists investigators with infomation and materials required to complete grant and contact applications for clinical trials. Collaborates with Principal Investigator to negotiate informed consent form with study sponsor or CRO Collaborates with staff of other departments to assess, plan, implement and evaluate the feasibility of the research protocol Departmental Organization Assists with orientation of new research and other departmental staff to assure compliance with NorthShore University Assist with upkeep and maintenance of clinical trial policy and procedure manuals P