Assistant Director, Clinical Research Operations

Job description

Hyde Park Campus

2012217 Medicine-Hem/Onc

About the Unit
The Section of Hematology/Oncology has a proud and long tradition of excellence in research-based patient care and clinical discovery. Ranked among the finest cancer programs in the country, the Section is comprised of nationally and internationally known faculty with expertise in all major types of malignancies, blood disorders, and experimental therapies.

Job Information

Job Summary:

The Assistant Director assists the Director of Clinical Research Operations in establishing standards and best practices for data management and data quality within the Section. This position will be responsible for ensuring Section-wide compliance with regards to our local Institutional Review Board (IRB), National Cancer Institute (NCI) guidelines, Good Clinical Practice (GCP) and FDA Regulations.

Responsible for recruitment, placement, and management of the research data managers assigned to industry sponsored, cooperative group and investigator initiated trials (IIT). Facilitate and provide quality assurance oversight to the research staff. Responsible for working with staff to ensure data completion is timely and accurate.

Responsible for developing and implementing new staff orientation materials for data managers and data quality personnel. Serves as a resource to principal investigators (PIs) and Section leadership on data management/data quality needs, feasibility assessments, compliance, and best practices. Develops and manages reports on key data. Ensures timeliness of data and reporting submissions from multiple investigators; establishes and implements consistent standards and protocols. Ensures ongoing competence of data managers and data quality personnel within the section, with both direct and indirect lines of reporting authority. Liaises with Section leadership, Research Managers, faculty, University Research Administration (URA), Office of Clinical Research (OCR), Institutional Review Board (IRB), and other key constituents throughout the University and network as needed.


Data Management:

  • Supervise, support and train data management staff within the Section; ensure contractual obligations regarding data entry are met.
  • Align staff based on disease programs, workload, sponsor databases, and/or therapeutic drugs
  • Liaise with Research Managers to review and manage trial priorities from a data management perspective and provide data management input into timelines.
  • Manage and/or participate in on-site monitoring visits and/or audits, including but not limited to, ensuring site readiness, organize PI and other internal meetings; determine compliance status and identify compliance risks.
  • Ensure monitoring visits, audits and inspections are executed successfully; assists with management of monitor and sponsor relationships.
  • Meet with monitors while on site and ensure disease programs complete outstanding items in follow up letters.
  • Organize staff to allow time to meet with monitors in an effort to reduce queries.
  • Work with Clinical Trials Financial Group (CTFG) to ensure data management needs are budgeted correctly.
  • Manage the monitoring room calendar and track the Monitoring Fee invoices for completed visits.

Data Quality:
  • Develop a data quality program for Investigator Initiated and Cooperative Group Trials.
  • Work with PIs to develop Case Report Forms (CRFs) for IIT Trials.
  • Develop a process for data reporting to PIs on IIT trials.
  • Develop streamlined process for data collection on Section-wide biobanks.
  • Develop key quality metrics across disease programs and determine appropriate actions in conjunction with management.
  • Ensure data reporting and results reported to

  • Works with Section, department, and divisional leadership on strategic initiatives.
  • Collaborates with other institutional offices on initiatives related to clinical research conduct and operations.

Additional Requirements

Education Experience and Certifications:
  • Bachelor's degree required.
  • Master's degree preferred.
  • Research certification (e.g., Graham School, SoCRA, ACRP) preferred.
  • Seven years of clinical research experience or research experience combined with relevant experience required.
  • Three years of staff management and/or supervisory skills required.
  • Experience managing research projects required.
  • Experience monitoring and auditing clinical research trials for compliance/billing accuracy (e.g., site monitoring, quality assurance, creation of monitoring plans) preferred.
  • Experience in a complex and demanding leadership role preferred.

Required Documents:
  • Resume
  • Cover Letter

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

Benefit Eligibility

Pay Frequency

Pay Range
Depends on Qualification

Scheduled Weekly Hours


Job is Exempt?

Drug Test Required?

Does this position require incumbent to operate a vehicle on the job?

Health Screen Required?

Posting Date

Remove from Posting On or Before

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.

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Full time

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.

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Job No:
Posted: 6/15/2018
Application Due: 7/14/2018
Work Type: