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Clinical Research Coordinator 2, Department of Surgery

University of Chicago

BSD SUR - Research Services is a part of the University of Chicago's Department of Biomedical Sciences. Since 1927, scientists in the department, including Nobel laureate Charles B. Huggins, MD, have advanced research in areas such as immunotolerance, vaccine stabilization, and bioengineering. The department values rigorous inquiry and offers a dynamic, collaborative environment. Job Summary The Clinical Research Coordinator 2 (CRC2) works with the Principal Investigator, co-investigators, and study personnel to administer and guide compliance, financial, and operational aspects of clinical studies under limited departmental direction. Responsibilities Manage multiple moderately complex clinical trials, including national-level and multi-institutional pharmaceutical studies. Recruit, screen, obtain informed consent, enroll subjects, and conduct follow-up, including data collection and case report form completion. Serve as liaison between sponsor and PI, conduct sponsor-related visits, and participate in study start-up activities. Collaborate with lab teams to process, collect, ship, and store specimens using aseptic techniques. Plan and coordinate subject schedules for procedures and treatments, educate subjects about protocols, and monitor for adverse events. Identify and report adverse events, protocol deviations, or violations to PI, sponsor, and IRB. Facilitate site visits from sponsors and other relevant meetings. Maintain a safe research environment and ensure compliance with government and university regulations. Data Management Control acquisition, abstraction, processing, privacy, and quality assurance of all clinical research data per protocol specifications. Ensure source documentation and data entry accuracy, work with monitors and auditors to resolve data quality concerns, and support data exchange across projects. Protect patient confidentiality by securing research data and protecting PHI in compliance with federal regulations and sponsor protocols. Implement and document SOPs in accordance with sponsor, PI, and regulatory agency specifications. Regulatory Compliance Maintain accurate and complete records, including signed consents, IRB approvals, and study communications. Ensure compliance with federal regulations and institutional policies. Mentor junior staff on GCP, GDP, SOPs, and related clinical study aspects. Other Responsibilities Assist with professional, organizational, and operational tasks under moderate supervision. Coordinate collection of analyzable data and participation in audits. Contribute to problem-solving on assigned studies. Perform other related work as needed. Education Bachelor’s degree in a related field. Work Experience 2–5 years of experience in a related discipline, with knowledge and skills developed through practical work. Preferred Qualifications Experience coordinating multiple investigator-initiated, industry-sponsored, or multi-site trials. Management & Regulatory Compliance certification. Knowledge of patient evaluation, triage procedures, and monitoring of research patients. Strong data management skills and attention to detail. Ability to review and understand clinical trial protocols. Familiarity with GCP and IRB submission processes. Understanding of federal research regulations and human research participation oversight. Proficiency with Microsoft Word, Excel, and Adobe Acrobat. Excellent communication skills with staff, faculty, and patients. Benefits Full salary and benefits package including health, retirement, and paid time off. Pay Range $60,000.00-75,000.00 (Salary) Drug, Health, and Background Screen Requirements Drug test required. Health screening required. Background check conducted; conviction history reviewed on a case-by-case basis. EEO 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, disability, veteran status, genetic information, or other protected classes under the law. All employment offers are contingent upon a background check and offer is at the University’s sole discretion. #J-18808-Ljbffr

Vacancy posted more than 2 months ago

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