Regulatory Affairs Manager

Department
 

BSD ACC - Research

About the Department
 

The Department of Anesthesia & Critical Care is a clinical academic department at the University of Chicago. The department has been continuously productive not only in its scientific contributions, but also in providing outstanding basic medical care in anesthesiology. Its members have helped to establish the role of anesthesiologists as consultants in fields such as intensive care, oxygen therapy, the recovery room, and inhalation therapy. From a one-member section
in 1928, the department has grown to a 80+ member faculty; the department includes 70+ residents, 65+ nurse-anesthetists, 14 administrators and 70+ staff members. Faculty members are active nationally and internationally in the field, and former trainees of the department hold prominent academic positions in the United States and throughout the world.

Job Summary
 

The Regulatory Affairs Manager will manage regulatory functions for studies conducted in the Department of Anesthesia & Critical Care.

Responsibilities

• Regulatory Affairs Managers handle all regulatory functions for a large portfolio of studies. 

• This includes Institutional Review Board (IRB) approval, all specialty subcommittee reviews, and FDA IND and IDE submission. 

• Regulatory Affairs Managers serve as liaisons between principle investigator, co-investigators, sponsoring agents, regulatory agencies, and other members of the research team.

• Regulatory Affairs Managers lead PI’s and study teams in meeting internal and external regulatory compliance requirements, and serve a vital role during study audits.

• Partner with PI study team to maximize clinical research efficiency and progress.

• Consult with PI team regarding strategic planning around clinical research portfolios.

• Participate in protocol writing.

• Facilitate study initiation through thoughtful and timely preparation of IRB, sub-committee and FDA submissions.

• Prepare and maintain all materials related to IRB and FDA approvals.

• Ensure successful monitoring and auditing of studies including FDA, sponsor and/or internal study audits.

• Present research portfolio progress during research team meetings.

• Provide guidance to faculty regarding compliance, funding and research support resources.

• Maintain a high level of self-education to include review of articles related to clinical research; attend multi-disciplinary conferences; attend workshops specific to clinical research.

• Assist in the orientation and training of new and current Clinical Research Support Office staff and/or staff in the various sections of the Department of Medicine.

• 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.

Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Experience:

• Project management.

• Regulatory compliance.

• Clinical research and/or data management.

• Experience at a large academic or medical institution.

Technical Skills or Knowledge:

• Proficiency with Microsoft Word and Excel.

• Proficiency with Adobe Acrobat.

Preferred Competencies

• Outstanding project management.

• Excellent verbal and written communication skills.

• Ability to manage stressful situations.

• Analytical thinking and problem-solving.

• Attention to detail.

• Strong organizational skills.

• Strong Interpersonal skills.

• Work independently with a high degree of initiative.

• Work as part of a team.

• Ability to maintain confidentiality.

Application Documents

• Resume (required)

• Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family
 

Legal & Regulatory Affairs

Role Impact
 

Individual Contributor

FLSA