Regulatory Affairs Manager

Location
Chicago, IL
Posted
Feb 21, 2018
Institution Type
Four-Year Institution


Hyde Park Campus

Department

About the Unit
The mission of the Clinical Research Support Office (CRSO) is to promote and facilitate the conduct of clinical research in the Department of Medicine. The Department of Medicine has a long tradition of conducting original and rigorous biomedical and clinical research of fundamental significance. The CRSO assists in the expansion of this remarkable research program by providing centralized support services for our faculty.

Job Information

Job Summary:

The Regulatory Affairs Manager functions as an essential members of our dynamic clinical research team by managing regulatory functions for studies conducted in the Department of Medicine. These clinical research studies may involve various areas of medicine and modalities of treatment. Research projects include investigator authored studies, as well as industry sponsored research. 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 approvals. Regulatory Managers serve as liaisons between principle investigator (PI), co-investigators, sponsoring agents, regulatory agencies, and other members of the research team. Regulatory Managers lead PI's and study teams in meeting internal and external regulatory compliance requirements, and serve a vital role during all study audits.

Responsibilities:
  • Partner with PI study team to maximize clinical research efficiency and progress
  • Consult with PI team regarding strategic study planning
  • Participate in protocol document writing
  • Facilitate study initiation through meticulous and timely preparation of IRB, sub-committee and FDA submissions
  • Prepare and maintain all materials related to IRB and FDA approvals throughout the life of the study
  • 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 work area
  • 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


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.
  • Proficiency with Microsoft Word and Excel required.
  • Proficiency with Adobe Acrobat preferred.


Additional Requirements

Education and Experience:
  • Bachelor's degree required.
  • 1-2 years of project management experience required.
  • Regulatory compliance experience preferred.
  • Clinical research and/or data management experience preferred.
  • Experience at a large academic or medical institution preferred.


Benefit Eligibility
Yes

Pay Frequency
Monthly

Pay Range
Depends on Qualification

Scheduled Weekly Hours
37.5

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
Yes

Does this position require incumbent to operate a vehicle on the job?
No

Health Screen Required?
Yes

Background Check Required?

Yes

Posting Date
2018-01-31-08:00

Remove from Posting On or Before
2018-07-31-07:00

Posting Statement:

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected 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 773-702-5800 or submit a request via Applicant Inquiry Form.

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: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

Full time
JR00417

About Us
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.

We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.

To learn more about the university click here http://www.uchicago.edu/

PI101288611

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