Qualifications/Knowledge, Skills & Abilities
Bachelor degree required, preferably in a research, scientific or related technical field;
Previous work history demonstrating a high level of organizational and methodical and analytical thinking and problem solving skills:
The ability to work independently and as a leader of a team;
Candidate must be fluid in "multi-tasking"
Extensive knowledge of both DHHS (45 CFR 46) and FDA (21 CFR 50 and 56) human subjects regulations and appreciation of related regulatory, ethical and compliance principles;
Current working knowledge of additional regulations and guidance (e.g., HIPAA) applicable to biomedical human subject research studies;
Minimum of 5 years of experience in IRB administration, management and IRB policy, preferably with an academic institution, hospital, government or research based organization;
Experience conducting exempt determinations and/or expedited reviews;
Requires excellent organizational skills and strict attention to detail.
Knowledge and experience with IRB accreditation standards and processes
Communication and other skills:
This position requires strong oral and written communication skills
Demonstrated interpersonal skills necessary to interact with multiple individuals and entities across a large, two campus academic organization.
Competence with Microsoft Office Suite and other data management systems
Master's degree (MBA/MPH/MS/MA) preferred;
Membership in national or regional human subjects organization (PRIM&R) preferred;
Current Certified IRB Professional (CIP) preferred or willingness to obtain certification;