Regulatory Compliance Specialist at The University of Chicago in Chicago, Illinois

Posted in Other 12 days ago.





Job Description:

Department



BSD CCC - Clinical Trials Office



About the Department



The University of Chicago Medicine Comprehensive Cancer Center (UCCCC) is an integral component of the University of Chicago Medicine and the Biological Sciences Division (BSD), the largest of four Divisions of the University that also includes the Pritzker School of Medicine. The UCCCC administers 6 established scientific programs, and the Cancer Center Support Grant from the National Cancer Institute provides funding for 11 Shared Facilities. The Center comprises over 215 faculty members from over 20 departments, with members being awarded over $60 million Direct Costs in peer-reviewed cancer research grants, and $17 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied including research, patient education and support, fundraising, marketing, clinical trials management, community outreach, and grant administration. The UCCCC facilitates interactions between laboratory, clinical and population scientists to foster discovery and its translation into direct benefit to patients and the general public. The Cancer Center has an extremely active clinical trials research program with over 1000 clinical research studies, many of which are also conducted at UCCCC affiliate institutions (approximately 40). Community researchers also strive to eliminate health disparities among ethnic or social groups.



Job Summary



The job 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.



Responsibilities



  • Preparation and submission to the IRB and other applicable internal review committees including submission of new study applications, amendments, and continuing reviews.

  • Creation and maintenance of site regulatory files for each assigned study.

  • Communication of updates and changes (e.g. protocol amendments) to the clinical research team and sponsor/funding agencies.

  • Participation in internal clinical research audit program (as assigned).

  • Multi-site Regulatory Coordination (as assigned): Act 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, and collection of site specific essential documents (IRB approvals, Form FDA 1572, staff qualifications and signatures, etc.), maintenance of up-to-date regulatory files for external participating sites.

  • Preparation and collection of all necessary documents to activate protocols (e.g. consent forms, Form FDA 1572, etc.).

  • Preparation of protocol updates and coordination of weekly program meetings and distribution of relevant updates to participating sites (as applicable).

  • Provides confidential and high-level administrative support for a leader. Stays informed of activities relating to University programs and initiatives, apprising the leader of issues when deemed necessary. Coordinates information flow from leader's office to University. May staff Board of Directors meetings. Relieves leaders of administrative responsibilities.

  • Initiates correspondence and other written materials under own signature or for signature of the leader. Triages emails and telephone calls for action. Resolves routine and complex inquiries. May act as liaison to Board of Directors

  • Prepare special reports and summaries, assists in managing daily operation of the office, and may assist in developing administrative goals and policies. Maintains the leader's calendar, exercising considerable discretion and judgment as to priorities and effective use of the leader's time.

  • Coordinates special projects as directed by the leader. Prepares write ups for recommendations for operational and administrative problems. May manage a portion of the leader's budget, monitoring and reconciling accounts. Prepares financial and/or administrative reports.

  • Performs other related work as needed.




Minimum Qualifications




Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

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Work Experience:


Minimum requirements include knowledge and skills developed through 7+ years of work experience in a related job discipline.

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Certifications:





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Preferred Qualifications




Experience:



  • 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).



Preferred Competencies



  • Solid understanding of regulations covering clinical trials/human subjects research.

  • Excellent computer skills, including familiarity with Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat.

  • Familiarity with clinical trial management systems and/or databases.

  • Excellent written and interpersonal skills. Ability to effectively present oral and written information.

  • Analytical, problem solving, and decision making skills.




Application Documents



  • Resume (required)

  • Cover letter (preferred)



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



Job Family



Administration & Management



Role Impact



Individual Contributor



FLSA Status



Non-Exempt



Pay Frequency



Biweekly



Scheduled
Weekly Hours



20



Benefits Eligible



Yes



COVID-19 Vaccination or Approved Medical or Religious Exemption Required



Yes



Drug Test Required



No



Health Screen Required



No



Motor Vehicle Record Inquiry Required



No



Posting Statement



Effective October 15, 2021, the University of Chicago requires COVID vaccination for all students, faculty, and staff members. Individuals may claim exemption from the vaccine requirement for medical or religious reasons.


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.


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 case-by-case 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: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.
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