This position manages the day to day operations of the Institutional Review Board (IRB) of Children's Memorial Research Center (CMRC).

ESSENTIAL JOB FUNCTIONS

• In collaboration with other IRB Manager(s), manages the day to day operations of the Institutional Review Board (IRB); plans, and facilitates regular and special meetings of the IRB. Supervises, (and provides training as needed) and evaluates IRB staff.
• Coordinates large scale projects related to the improvement of IRB processes and regulatory compliance, such as implementation of electronic submissions, training and outreach sessions, and development of IRB policies and procedures. Works with IRB staff, IRB Chair and Director to prepare initial accreditation documents and annual accreditation reports to maintain accreditation. Works with IRB Chair and Director to orient to IRB members. Ensures roster is compliant with OHRP and FDA requirements.
• Advises and guides Principal Investigators (PIs) on PHS, FDA, HIPAA, and institutional regulations, policies, procedures, guidelines, and deadlines on a daily basis. Interacts regularly with a wide variety of internal and external contacts including but not limited to PIs, Division and Department Heads, representatives from federal and state agencies, non-profit agencies, and corporate sponsors of research on a regular basis; provides guidance on the IRB application and review process; interprets IRB regulations, and acts as a liaison to the IRB Chair and external agencies. Manages communications to PIs; notifies PIs of IRB decisions, requests additional information when required and coordinates supplementary materials required by the IRB including the preparation and distribution of information.
• Manages information to support the IRB function including minutes, agendas, and other correspondence. Responsible for working with staff in compiling and writing of minutes. Evaluates IRB applications for completeness and conformance to IRB application rules. Alerts IRB Chair to protocol issues that may need closer review. Maintains IRB files and databases. Generates IRB statistical reports based on databases.
• Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers and others. Supports the Director, Office of Research Integrity and Compliance, on IRB related regulatory and assurance issues.

FTE status: FT-80

Requirements

• A level of knowledge normally acquired through the completion of a Bachelor's Degree (unspecified area).
• One to three years of research administration or regulatory review committee experience in a hospital, university or other research setting.
• Certified IRB Professional (CIP) preferred.
• Strong interpersonal skills necessary to interact and communicate effectively with physicians, Principal Investigators, and medical center personnel, and external funding agencies, and to maintain a variety of internal and external contacts.
• Possess an excellent command of the English language; medical terminology is required.
• Organizational skills: Ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
• Demonstrated knowledge of Microsoft Office and other computer software is required.