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Sr. Clinical Research Coordinator

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Friday, January 26, 2024

Department

BSD CCC - Network Oncology Research


About the Department

The University of Chicago Comprehensive Cancer Center (UCCCC) is an integral component of the Biological Sciences Division (BSD). The BSD is the largest of four Divisions of the University and includes the Pritzker School of Medicine. UCCCC administers four established scientific programs, and the NCI-sponsored Cancer Center Support Grant provides funding for ten Shared Resources. The Comprehensive Cancer Center is comprised of over 150 faculty members from twenty departments with members currently being awarded over $47 million in total direct costs in peer-reviewed cancer research grants, and $28 million in non-peer reviewed grants and contracts. The activities of the Center are broad and varied, including research, training and education, communications, fundraising, marketing, clinical trials management and community outreach.

UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area with nearly 500 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies. UCCCC opens over 250 new trials each year and accrues approximately 900 participants to therapeutic trials each year.


Job Summary

The Senior Clinical Research Coordinator (Sr. CRC) is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager within the Section of Hematology/Oncology in the Department of Medicine. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr. CRC oversees, facilitates and coordinates the daily activities of complex clinical trials and plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations.

Responsibilities

  • The Sr. CRC acts as a leader within the department/unit through improving clinical research practice and serves as a resource to others.

  • By performing these duties, the Sr. CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical studies. other related aspects of the clinical study.

  • Assist with or plan and implement the clinical study's goals and objectives; organize patient enrollment planning; conduct quality assurance activities, compile and analyze data.

  • Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.

  • Serve as a resource person or act as a consultant within area of clinical expertise.

  • Act as a leader within the department/unit through improving clinical research practice and serving as a resource.

  • Maintain working knowledge of current protocols, and internal SOPs.

  • Be accountable for high standards of clinical research practice and assist in the development of accountability in others.

  • Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.

  • Oversee and participate in the coordination and conduct of complex clinical research studies and ensure compliance with federal and institutional regulations.

  • Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).

  • Provide Investigators with guidance regarding protocol requirements.

  • Maintain regulatory documentation.

  • Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.

  • Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.

  • Provide direct supervision of other CRC staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.

  • Attend continuing education and training opportunities relevant to job duties.

  • Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators.

  • Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools.

  • 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 5-7 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Bachelor’s degree.

Experience:

  • Experience coordinating multiple and a variety of studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Licenses and Certifications:

  • Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance) strongly preferred.

Preferred Competencies

  • Ability to train junior CRCs.

  • Ability to participate in protocol review and clinical trials evaluations.

  • Excellent interpersonal skills.

  • Strong data management skills and attention to detail.

  • Ability to handle competing demands with diplomacy and enthusiasm.

  • Ability to work collaboratively with faculty and divisional clinical research infrastructure.

  • Excellent time management and ability to prioritize work assignments.

  • Ability to read and understand clinical trials protocols.

  • Familiarity with medical terminology/environment.

  • Working knowledge of Good Clinical Practices (GCP).

  • Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.

Working Conditions

  • Hybrid position with majority of work being done in-person/ on-site.

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

Research


Role Impact

Individual Contributor


FLSA Status

Exempt


Pay Frequency

Monthly


Scheduled Weekly Hours

40


Benefits Eligible

Yes


Drug Test Required

Yes


Health Screen Required

Yes


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.

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