Lead Research Regulatory Specialist

Position Introduction:

The Research Regulatory Specialist supports the research compliance and regulatory affairs functions of the Department of Surgery. This is designed for a motivated individual who is eager to learn research administration from the ground up. The successful candidate will work closely with and be mentored by our Director of Research gaining hands-on experience across IRB IACUC and IBC compliance processes clinical trial regulatory management faculty-facing guidance and institutional liaison work. This role is ideal for someone who is detail-oriented curious and a self-starter. Someone who takes ownership of tasks asks good questions and is willing to contribute wherever needed. Over time this person is expected to develop into an independent resource for faculty and staff across the full range of departmental research compliance functions.

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Required Education and Experience:

• Bachelors Degree
• 36 months of regulatory experience in a clinical research environment.

Equivalency/Substitution: Will accept 48 months of equivalent regulatory experience in lieu of the Bachelors Degree for a total of 84 months experience.

Required Certifications and Licenses:

None

Department Preferences:

• Familiarity with IRB processes clinical research regulations (FDA ICH GCP) or research compliance concepts
• Prior experience in a clinical academic or research environment in any capacity
• Exposure to IACUC or IBC processes
• Experience with electronic IRB or regulatory submission systems