Sr. Clinical Research Coordinator at The University of Chicago in Chicago, Illinois

Job Description:

Department

BSD CCC - Network Oncology Research Support



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 190 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

• Assists with or plans and implements the clinical study goals and objectives; organizes patient enrollment planning; conducts quality assurance activities, compiles and analyzes data; processes blood and urine specimens.
  
  


• Acts as a liaison with medical staff, University departments, ancillary departments and/or network facilities.
  
  


• Acts as a leader within the department/unit through improving clinical research practice; serves as a resource person or acts as a consultant within area of clinical expertise.
  
  


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


• Accountable for high standards of clinical research practice and assists in the development of accountability in others.
  
  


• Develops and implements procedures, maintains records, tracks progress, and conduct quality assurance on data collected.
  
  


• Provides investigators with guidance regarding protocol requirements. Maintains regulatory documentation.
  
  


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


• Prepares for and assists with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
  
  


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


• Accountable for all tasks in complex clinical studies.
  
  


• Performs various professional, organizational, and operational tasks under limited supervision. Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff. Accountable for complex problem solving on assigned clinical research studies and professional tasks.
  
  


• Facilitates and participates in the daily activities of complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Uses in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
  
  


• Performs other related work as needed.
  
  

Minimum Qualifications




Education:

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



Work Experience:

Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.



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 and Regulatory Compliance.
  
  

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) MUSTbe uploaded via the My Experience page, in the section titled Application Documents of the application.



Job Family

Research



Role Impact

Individual Contributor



Scheduled
Weekly Hours

40



Drug Test Required



Yes



Health Screen Required



Yes



Motor Vehicle Record Inquiry Required



No



Pay Rate Type

Salary



FLSA Status

Exempt



Pay Range

$66,500.00 - $100,000.00
The included pay rate or range represents the University's good faith estimate of the possible compensation offer for this role at the time of posting.



Benefits Eligible

Yes
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.



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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