Associate Director, Research Operations and Conduct

Location
Chicago, IL
Posted
Apr 03, 2018
Executive Administration Jobs
C-Level & Executive Directors
Institution Type
Four-Year Institution


Hyde Park Campus

Department
2010052 BSD - Office of Clinical Research

About the Unit
The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. To provide the highest level of support and resources, the Office of Clinical Research is divided into two groups- the Institutional Review Board Administrative Staff (IRB) and the Research Operations and Conduct group (ROC). The OCR focuses on six key areas of service including: Human Subject Protection (IRB); Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure.

Job Information

Job Summary:

The Associate Director- Operations and Conduct is an integral member of the OCR team who will promote and facilitate a culture of compliance by providing instruction, support, and guidance to faculty/investigators, research staff, clinical staff and administrators in the performance of clinical research. The Associate Director – Operations and Conduct assists the Director of Research Operations and Conduct in establishing standards and best practices, developing and fulfilling standard operating procedures, policies and practices; coordinating system changes; implementing educational and training programs; developing communication tools; and managing the administrative functions that impact individuals involved in clinical research to ensure appropriate oversight of clinical research conduct, fulfillment of regulatory responsibilities, data integrity, and research billing compliance.

Responsibilities:
  • Serves as a primary point of contact for faculty and research staff with regulatory, operational, and compliance questions or needs related to fulfilling their regulatory obligations and research program initiatives.
  • Facilitate research staff and faculty in using systems to support research conduct and regulatory activities including the electronic medical record (Epic), clinical trial management system, data capture systems (e.g., RedCap), clinicaltrials.gov, IRB systems, etc.
  • Proposes best practice guidelines, write standard operating procedures, distribute educational material, and provide training in order to promote understanding and adherence of clinical research regulations and responsibilities, local policies, and best practices.
  • Manage quality assurance activities within the research operations and conduct (ROC) team to ensure adequate quality control measures and documentation of processes and quality assurance guidelines as mandated by regulatory agencies (FDA, NIH, OPHR) are met.
  • Work closely with IRB administrative staff, ROC staff and OCR leadership to facilitae and manage clinical research oversight and support activities such as, but not limited to, new study review, creation of study records into electronic systems, amendments, clinicaltrials.gov, etc.
  • Perform quality assurance activities including, but not limited to: internal conduct audits, data quality audits, research billing audits, etc. to ensure quality control and compliance with guidelines as mandated by regulatory agencies (FDA, NIH, OHRP, CMS).
  • Produce, analyze, and distribute reports to departmental research leaders and research staff to communicate current compliance with internal policies and procedures; manage status of required actions in order to improve data quality, system usage, and workflow.


Competencies:
  • Ability to work with minimal supervision and function as a team member required.
  • Demonstrated accuracy and precision and attention to detail
  • Strong organizational and project management skills
  • Expertise in Microsoft Excel, Access, and PowerPoint
  • Excellent written and verbal communication skills, including presentation skills


Additional Requirements

Education, Experience and Certifications:

Education:
  • Bachelor's degree required


Certifications:
  • Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP) preferred


Experience:
  • Minimum of five years of clinical research management or clinical research compliance experience required
  • Advanced 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 required
  • 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 required
  • Ability to manage large quantities of data in a manner which facilitates sharing of information and reporting of key performance indicators and metrics


Required Documents:
  • Cover Letter
  • Resume

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

Benefit Eligibility
Yes

Pay Frequency

Pay Range
Depends on Qualification

Scheduled Weekly Hours
37.5

Union
Non-Union

Job is Exempt?
Yes

Drug Test Required?
No

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

Health Screen Required?
No

Posting Date
2018-04-02-07:00

Remove from Posting On or Before
2018-10-02-07:00

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
JR00947

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/

PI101868855

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