IRB Manager
- Research Integrity & Compliance
- Chicago (Lincoln Park)
- Full time
- Days
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.