Jul 11, 2019
Full time
Oversee and facilitate the coordination of the protocol review process in accordance with the University's Human Research Protection Program. CORE DUTIES*:
Develop, implement, and manage efficient procedures to facilitate the processing of human research protocols in accordance with, 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.
* - Other duties may also be assigned
Education & Experience:
Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
Knowledge, Skills and Abilities:
Comprehensive knowledge of regulatory information regarding the use of human participation in research and teaching.
Demonstrated understanding of the principles of human research protection standards.
Strong knowledge of grants and contracts function.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
Demonstrated strong verbal and written communication skills.
Knowledge of human subjects and federal and state policies and procedures.
Knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
Certifications and Licenses: Institutional Review Board professional certification desirable.
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