JOB POSTING #891
Starting Salary: Dependent Upon Qualifications
Closing Date: Until Filled
Under the direction of the Associate Provost for Research and the Director of Research Administration, the IRB Manager conducts in-depth protocol review using advanced regulatory knowledge and experience. S/he has primary responsibility to manage the protocol review process and identify issues, and to independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, CGU policies, and accreditation standards. Other duties include serving as an expert liaison between the research investigator and the reviewer; educating parties on relevant and emerging regulations, and identifying related risk management issues.
- Develop, implement, and manage efficient procedures to facilitate the processing of human research protocols in accordance with CGU, federal, accreditation, and state policies and procedures
- Perform review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.
- Plan and coordinate monthly IRB review and follow-up activities.
- Serve as an expert liaison between the research investigator and the reviewer, educate parties on relevant and emerging regulations and related risk management issues.
- Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
- Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities qualifications.
- Excellent customer service skills and ability to use tact and discretion
- Comprehensive knowledge of regulations and ethical principles regarding human subjects in research, principally in the behavioral sciences.
- Demonstrated understanding of research procedures terminology and research data management.
- In-depth understanding of operational requirements pertaining to management and implementation of protocol process
- Strong knowledge of grants and contracts function
- Demonstrated strong verbal and written communication skills.
- Other related duties as assigned.
REQUIRED KNOWLEDGE, SKILLS, and ABILITIES:
Individual must possess knowledge, skills and ability to be able to successfully perform the essential functions of the position, or be able to explain or demonstrate how the essential functions will be performed, with or without reasonable accommodation, using some other combination of skills and abilities.
May supervise Administrative Assistant/IRB Coordinator to ORSPG.
A Bachelor’s degree, master preferred, or any combination of education and experience equivalent to graduation with a Bachelor’s degree. Basic certification of training in human subject’s protection (CITI or equivalent) is required or any combination of education, training or experience that provides required knowledge, training and ability. Evidence of advanced training such as CIM or CIP certification is preferred and will be required of incumbent in due course. Six + years of related experience with at least two years of protocol reviewing experience applying DHHS human subject protection regulations and guidelines in a university or equivalent research environment.