Department
About the Department
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 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.
This position 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.
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 conductsquality assurance on data collected.Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations. Prepares, submits, and assists Investigators with multiple levels of research documentation, i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms.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.Provides direct supervision of other CRC staff, including but not limited to, hiring/firing, performance evaluations, disciplinary actions, manage time off, etc. Attends 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.---
Work Experience:
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Certifications:
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Preferred Qualifications
Education:
Bachelor’s degree.Experience:
Minimum of 5 years of clinical research experience coordinating multiple and variety of studies, e.g.,investigator initiated; industry sponsored; multi-site trials.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.Technical Skills or Knowledge:
Train junior CRCs.Participate in protocol review and clinical trials evaluations.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.Preferred Competencies
Excellent interpersonal skills.Strong data management skills and attention to detail.Handle competing demands with diplomacy and enthusiasm.Work collaboratively with faculty and divisional clinical research infrastructure.Excellent time management and prioritize work assignments.Working Conditions
Bend, crouch, or stoop.Lift loads up to 49 lbs.Hybrid position with majority of work being done in-person/ on-site.Application Documents
Resume/CV (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
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.
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