Regulatory Affairs Manager - Chicago, United States - Workday

Description

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 onemember section
in 1928, the department has grown to a 80+ member faculty; the department includes 70+ residents, 65+ nurseanesthetists, 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, coinvestigators, 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, subcommittee 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 selfeducation to include review of articles related to clinical research; attend multidisciplinary 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.
Work

Experience:
Minimum requirements include knowledge and skills developed through 25 years of work experience in a related job discipline.
Certifications: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 problemsolving.

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 Status

Exempt
Pay Frequency

Monthly
Scheduled

Weekly Hours

37.5
Benefits Eligible

Yes
Drug Test Required

No
Health Screen Required

No
Motor Vehicle Record Inquiry Required

No
Posting Statement

The University of Chicago is an

Affirmative Action/Equal Opportunity/Disabled/Veterans

and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.

For additional information please see the

University's Notice of Nondiscrimination.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call

or submit a request via

Applicant Inquiry Form.

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

All offers of employment are contingent upon a background check that includes a review of conviction history.

A conviction does not automatically preclude University employment.

Rather, the University considers conviction information on a casebycase basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information.

The Report can be accessed online at:
. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL

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