at University of Chicago in Chicago, Illinois, United States
Job Description
DepartmentBSD OCR - Clinical Research Incubation
About the Department
The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency, and collaboration across the Biological Sciences Division and UChicago Medicine.
The mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.
Job Summary
The Clinical Research Coordinator I (CRC1) is a specialized research professional working with and under the direction of the Principal Investigator (PI), Co-investigator(s), and other study personnel to follow the clinical protocol. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of clinical trials, the CRC 1 is delegated to perform study related tasks across the life cycle of the study. The CRC1 plays a critical role in the conduct of the studies to ensure compliance with federal and institutional regulations. This position is housed within a central core but will work specifically with investigators in the Orthopedic Surgery Department. By performing these duties, the CRC 1 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
Regulatory:
- 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).
- Follow protocol manual of operations.
- 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.
Research Conduct/Study Management:
- 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 clinical staff, university departments, ancillary departments and/or satellite facilities.
- Serve as a resource person or act as a consultant within area of clinical expertise.
- Support the department/unit with active quality improvement activities in 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.
Data Management:
- Follow procedures, maintain records, track progress, and respond to data queries in timely manner.
- 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.
- Understands protocols and advises treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).
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Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
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Certifications:
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Preferred Qualifications
Education:
- A college or university degree in related field.
Experience:
- Knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Preferred Competencies
- Strong knowledge of clinical research regulations and best practices.
- Excellent time management and ability to prioritize work assignments.
- Ability to read and understand clinical trial protocols.
Working Conditions
- Clinical Environment.
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
FLSA Status
Non-Exempt
Pay Frequency
Biweekly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
No
Health Screen Required
No
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.
