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Research Compliance Specialist

University of Chicago

University of Chicago

Legal
Chicago, IL, USA
Posted on Thursday, January 18, 2024

Department

BSD OCR - Office of Clinical Research


About the Department

The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.

To mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.

The Research Compliance section provides oversight, resources and training for compliant conduct of clinical research, with focus on process improvement & customer service.


Job Summary

The job maintains regulatory compliance programs, including the interpretation of systems to identify areas of risk and coordinate internal audits. With a moderate level of direction, participates in compliance documentation and compliance training.

Responsibilities

  • Performs Clinical Research Compliance Audits.

  • Conducts audits to document compliance with UChicago policies, GCP, Federal, state and local regulations.

  • Provides written audit and investigation reports, identifying risks and recommendations for interventions to improve effectiveness and mitigate risk.

  • Review all corrective action plans for identified deficiencies and track effectiveness of interventions for effectiveness and risk mitigation.

  • Track and rend research compliance related allegations, investigations and outcomes.

  • Performs Clinical Research Compliance Training & Education.

  • Contributes to divisional clinical research training portfolio, training plans, coordination of speakers and frequency of modules and topics.

  • Trend and analyze effectiveness of training offerings.

  • Serve as divisional subject matter expert regarding clinical research compliance.

  • Publish and maintain website with tools, templates and resources that support divisional clinical research compliance.

  • Provides Clinical Research Regulatory & Compliance Support.

  • Provides support for ClinicalTrials.gov.

  • Metrics Development and Reporting.

  • Supports OCR initiatives by trending, tracking and setting targets to measure impact of compliance activities.

  • Collaborates with Clinical Research Stakeholders for projects across the division focusing on increasing efficiencies and risk mitigation.

  • 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.


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

Education:

  • CITI Human Subject Protection & Good Clinical Practice.

Experience:

  • Knowledge of Clinical Research Operations best practices.

  • Knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines.

  • Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies.

  • Familiarity with large healthcare information systems and/or past experience with EPIC experience.

Technical Skills or Knowledge:

  • Demonstrable organizational and project management skills.

  • Expertise in Microsoft Excel, Access, and PowerPoint.

Preferred Competencies

  • Strong analytical, organizational and report writing skills.

  • Excellent interpersonal and communication skills (oral/written).

  • Ability to work as part of collaborative team as well as autonomously.

Working Conditions

  • Office Environment.

Application Documents

  • Resume (required)

  • Cover Letter (preferred)


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

40


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 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.