Regulatory Affairs Manager, Comprehensive Cancer Center

University of Chicago•Chicago, IL

1d•Onsite

About The Position

This position maintains clinical trial regulatory compliance programs, including the interpretation of systems to identify areas of risk and may coordinate internal audits. With a moderate level of direction, participates in compliance documentation, compliance training, and submission of documentation to required internal committees and groups.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.
Familiarity with clinical trial management systems and/or databases.
Solid understanding of regulations covering clinical trials/human subjects research.
Excellent written and interpersonal skills.
Effectively present oral and written information.
Analytical, problem solving, and decision making skills.

Nice To Haves

Two years of clinical research or directly related experience.
Prior clinical trial regulatory experience.
Completion of a certificate or degree program in clinical trial management /regulatory affairs or directly related field.

Responsibilities

Prepares and submits materials to the IRB and other applicable internal review committees, including new study applications, amendments, and continuing reviews.
Creates and maintains the site of regulatory files for each assigned study.
Communicates updates and changes, such as protocol amendments, to the clinical research team and sponsor/funding agencies.
Participates in internal clinical research audit program as assigned.
Provides multi-site regulatory coordination as assigned.
Acts as the primary regulatory liaison for external sites participating in clinical research projects coordinated by the University of Chicago, including distribution of protocol documents and amendments; review of site consent forms; collection of site specific essential documents, including IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.; and maintenance of up-to-date regulatory files for external participating sites.
Prepares and collects all necessary documents to activate protocols, such as consent forms and Form FDA 1572, etc.
Prepares protocol updates, coordinates weekly program meetings, and distributes relevant updates to participating sites as applicable.
Coordinates department or clinic compliance with a moderate level of guidance.
Plans and executes internal and external audits and activities to support regulatory agency inspections.
Prepares, completes and submits all compliance documentation on a routine basis.
Coordinates compliance committee meetings.
Performs other related work as needed.