Clinical Research Coordinator II - Gastroenterology

Department BSD MED - Gastroenterology - Clinical Research Staff About the Department The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialty nationally by U.S News and World Report. With nearly 30 specialists on staff, our program plays a leading role in the understanding of digestive diseases and in developing innovative and successful treatments for patients. Since forming the nation’s first full-time department of gastroenterology in 1927, our physicians have continually improved treatments for digestive tract and related disorders by combining medical research, education, and patient care at the highest level. Job Summary The Clinical Research Coordinator II (CRCII) is a specialized researcher, partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager in the Section of Gastroenterology in the Department of Medicine. Responsibilities Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports. Recruits and interviews potential study patients with guidance from PI and other clinical research staff. Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques. Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial. Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence. Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules. Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures. Performs assessments at visits and monitors for adverse events. Organizes and attends site visits from sponsors and other relevant study meetings. Protects patients' and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols. Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications. Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication. Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently. Ensures compliance with federal regulations and institutional policies. May prepare and maintain protocol submissions and revisions. Assist in the training of new or backup coordinators. 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. Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study. Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. Accountable for all tasks in moderately complex clinical studies. 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 2-5 years of work experience in a related job discipline. Certifications: --- Preferred Qualifications Education: Bachelors degree. Experience: Clinical research experience or relevant experience. Coordinating multiple studies, such as investigator initiated, industry sponsored, and multi-site trials. Technical Skills or Knowledge: Aware of safety hazards and take appropriate precautions. Comprehend technical documents. Create and deliver presentations. Preferred Competencies Communicate in writing. Communicate orally. Condense complicated issues to simple summaries that can be understood by a variety of constituents. Develop and manage interpersonal relationships. Exercise absolute discretion regarding confidential matters. Follow written and/or verbal instructions. Give directions. Handle sensitive matters with tact and discretion. Handle stressful situations. Learn and develop skills. Maintain a high level of alertness. Pay attention to detail. Perform multiple tasks simultaneously. Prioritize work and meet deadlines. React effectively, quickly, calmly, and rationally during conflicts and emergencies. Train or teach others. Work effectively and collegially with little supervision or as member of a team. Work independently. Application Documents Resume/CV (required) Cover Letter (required) The University of Chicago uses AI-assisted tools to streamline and augment some recruitment processes; however, AI is not used to make hiring decisions. When applying, the document(s) MUST be 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 $60,000.00 - $75,000.00 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 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. The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world. We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government. To learn more about the university click here