Sr. Clinical Research Coordinator
University of Chicago, Chicago, IL, United States
BSD CCC - Network Oncology Research Support
Job Summary
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 their conduct to ensure compliance with federal and institutional regulations. The Sr CRC serves as a leader within the department/unit by improving clinical research practices and 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, and reporting of clinical trial data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
Responsibilities
Assist with or plan and implement the clinical study 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.
Act as a leader within the department/unit through improving clinical research practice; serve as a resource person or consultant within the area of clinical expertise.
Maintain working knowledge of current protocols and internal SOPs.
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 of collected data.
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.
Attend continuing education and training opportunities relevant to job duties.
Accountable for all tasks in complex clinical studies.
Perform various professional, organizational, and operational tasks under limited supervision. Act 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.
Facilitate and participate in the daily activities of complex clinical studies and perform various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Use in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
Perform other related work as needed.
Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
Preferred Qualifications
Education: Bachelor's Degree in a related field.
Familiarity with Clinical trials terminology, environment, and protocols.
Working knowledge of Good Clinical Practices (GCP).
Minimum of 5 years of experience participating in protocol reviews and clinical trial evaluations.
Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Knowledge of the Microsoft Suite, including Outlook.
Ability to understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Adaptability to changing working situations and work assignments.
Working Conditions
Ability to navigate the UChicago Campus as required by the Position.
Hybrid work arrangements may be considered.
Schedule & Requirements
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: $70,000.00 - $85,000.00
Benefits Eligible: Yes
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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. 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.
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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Job Summary
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 their conduct to ensure compliance with federal and institutional regulations. The Sr CRC serves as a leader within the department/unit by improving clinical research practices and 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, and reporting of clinical trial data. Provides input into the strategic, administrative, operational, and financial decisions that impact clinical research conducted across the University.
Responsibilities
Assist with or plan and implement the clinical study 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.
Act as a leader within the department/unit through improving clinical research practice; serve as a resource person or consultant within the area of clinical expertise.
Maintain working knowledge of current protocols and internal SOPs.
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 of collected data.
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.
Attend continuing education and training opportunities relevant to job duties.
Accountable for all tasks in complex clinical studies.
Perform various professional, organizational, and operational tasks under limited supervision. Act 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.
Facilitate and participate in the daily activities of complex clinical studies and perform various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Use in-depth knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a high degree of independence.
Perform other related work as needed.
Minimum Qualifications
Minimum requirements include a college or university degree in a related field.
Work Experience
Minimum requirements include knowledge and skills developed through 5-7 years of work experience in a related job discipline.
Preferred Qualifications
Education: Bachelor's Degree in a related field.
Familiarity with Clinical trials terminology, environment, and protocols.
Working knowledge of Good Clinical Practices (GCP).
Minimum of 5 years of experience participating in protocol reviews and clinical trial evaluations.
Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Knowledge of the Microsoft Suite, including Outlook.
Ability to understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Adaptability to changing working situations and work assignments.
Working Conditions
Ability to navigate the UChicago Campus as required by the Position.
Hybrid work arrangements may be considered.
Schedule & Requirements
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: $70,000.00 - $85,000.00
Benefits Eligible: Yes
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, 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. 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.
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.
#J-18808-Ljbffr