Project Manager, Investigator Initiated Trials

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Tuesday, November 7, 2023


BSD SUR - Research Services

About the Department

Operating since 1927 on a strong foundation of multidisciplinary clinical and academic excellence, the University of Chicago Department of Surgery's mission is to meet the most challenging and complex health problems on both a local and global scale.

Many of our faculty members are known for their contributions to the advancement of groundbreaking surgical procedures and techniques, including minimally invasive surgery. In addition to our department's clinical work, our scientists pursue a diverse range of basic, translational, and clinical research projects, including studies on the gut microbiome, tissue bioengineering, stem cell research, cancer, and immunotolerance.

This ongoing work and achievement would not be possible without the cohesive effort and commitment of the faculty and staff. We are looking for high energy, collaborative individuals who share our commitment to improving the health of patients in the community and beyond.

Job Summary

Under moderate direction of the Clinical Research Manager, the Project Manager helps oversee the day-to-day activities and overall workflow of all investigator-initiated trials (IIT) within the Department of Surgery (DOS). Investigator Initiated trials are authored and executed by the DOS surgeons. These trials may be multi-center trials with other universities throughout the United States.


  • Assists with intake of the trials to ensure the principle investigator has the necessary support.

  • Processes and submits all types of research agreements such as data use agreements.

  • Assists in the design, development, implementation, and conduct of an effective monitoring program in accordance with Good Clinical Practice, institutional policies and procedures, and research protocols.

  • Ensures that the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards.

  • Coordinates upcoming and ongoing monitoring visits while meeting expected timelines.

  • Verifies that trial data entered on the Electronic Case Report Form is consistent with patient clinical notes and other source documentation (source data verification).

  • Supports the Clinical Research Manager with monitoring RedCap databases.

  • Provides guidance to outside universities/collaborators to ensure they are executing the research trial correctly.

  • Maintains working relationships with research partners across the Biological Sciences Division.

  • Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.

  • Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.

  • Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.

  • Performs other related work as needed.

Minimum Qualifications


Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.



Preferred Competencies

  • Excellent oral and written communication skills.

  • Strong project management skills, strategic problem solving and attention to detail.

  • Ability to understand complex protocols to assist with billing and budget discussions.

  • Motivated and detail-oriented.

  • Strong interpersonal skills.

  • Commitment to providing a high level of service.

  • Ability to work independently and as part of a team.

  • Ability to handle sensitive and confidential situations and information with absolute discretion.

  • Ability to work well under pressure.

  • Knowledge of Microsoft Office.

Application Documents

  • Resume (required)

  • Cover Letter (required)

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

Job Family


Role Impact

Individual Contributor

FLSA Status


Pay Frequency


Scheduled Weekly Hours


Benefits Eligible


Drug Test Required


Health Screen Required


Motor Vehicle Record Inquiry Required


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.

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