Sr. Clinical Research Coordinator

Senior Clinical Research CoordinatorThe 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.ResponsibilitiesAssists 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 the 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 conducts quality assurance of collected data.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.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 QualificationsEducation: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:---Preferred QualificationsEducation:Bachelor's Degree in a related field.Experience: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.Licenses and Certifications:Research certification, e.g., SoCRA, ACRP, Graham School Clinical Trials Management and Regulatory Compliance.Preferred CompetenciesAbility 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 ConditionsAbility to navigate the UChicago Campus as required by the Position.Hybrid work arrangements may be considered.Application DocumentsResume (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 FamilyResearchRole ImpactIndividual ContributorScheduled Weekly Hours40Drug Test RequiredYesHealth Screen RequiredYesMotor Vehicle Record Inquiry RequiredNoPay Rate TypeSalary?FLSA StatusExempt?Pay Range$70,000.00 - $85,000.00The 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 EligibleYesThe 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 StatementThe 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 View phone number on click.appcast.io 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.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: Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.