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Senior Clinical Research Coordinator

University of Chicago

University of Chicago

This job is no longer accepting applications

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Administration
Chicago, IL, USA
Posted on Saturday, November 18, 2023

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 job independently manages the collection, documentation, analysis of clinical trial data, and reporting of clinical research data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.

The Senior Clinical Research Coordinator (Sr CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, 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. 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.

Responsibilities

  • 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; process blood and urine specimens.

  • Act as a liaison with medical staff, university departments, ancillary departments and/or network 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, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc.

  • 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).

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 work arrangements will be considered.

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.

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.

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