Clinical Research Coordinator 2, Transplant Surgery

Overview Department BSD SUR - Research Services: Investigator Initiated Trials About The Department Since the founding of the Department in 1927, scientists including Nobel Prize winner Charles B. Huggins, MD, have made discoveries that influence standard clinical practice. Today, the Department pursues open, rigorous inquiry in biomedicine, tackling challenges in immunotolerance, vaccine stabilization, and bioengineering. We seek individuals who contribute to a dynamic, collaborative environment. Job Summary The Clinical Research Coordinator 2 (CRC2) is a specialized researcher who works with the Principal Investigator (PI), Co-Investigator(s), and other study personnel under supervision of the clinical research manager. With limited supervision, the CRC2 supports the administration of compliance, financial, and related aspects of the clinical study in collaboration with the PI, Co-Investigator(s), department, and sponsoring agencies. Responsibilities Research Conduct / Study Management: Manage multiple concurrent moderately complex clinical trials that may include national level and multi-institutional pharmaceutical studies. Recruitment and screening of study subjects, obtaining informed consent, enrollment, follow-up, data collection and analysis, case report forms (CRF), adverse event reports, and ensuring protocol adherence. Collaborate with the Transplant Institute to identify potential patients in all clinics. Conduct sponsor-related visits and serve as liaison between sponsor and PI. Review study portfolio with the PI on a regular basis. Assist in planning and identifying workflow for new clinical trials. Participate in study start-up activities. Coordinate with Transplant Pharmacy to ensure effective workflow and trial success. Work with the lab team to process and collect samples for internal processing. Plan and coordinate subject schedules for procedures, return visits, and treatments; educate subjects on procedures, reporting expectations, and risks/benefits; perform visit assessments and monitor adverse events. Collect, process, ship, and store specimens according to aseptic techniques. Identify adverse events and protocol deviations, reporting findings to PI, sponsor, and IRB under the clinical research manager’s direction. Organize and participate in site visits from sponsors and other study meetings. Maintain a safe research environment and ensure compliance with governmental and University policies, procedures, and regulations. Data Management Oversee acquisition/collection, abstraction, processing, privacy, and quality assurance for all protocol data; ensure timely, complete data collection, processing, analysis, and reporting; ensure source documentation and data entry at specified time-points; collaborate with monitors/auditors to resolve data quality concerns; facilitate data exchange across projects. Protect patient data confidentiality and PHI; ensure compliance with federal regulations and sponsor protocols. Ensure SOPs are implemented and documented per sponsor, PI, and regulatory specifications. Regulatory Compliance Collaborate with Regulatory Manager to maintain accurate records (e.g., informed consent, IRB approvals, study communications). Ensure compliance with federal regulations and institutional policies. Mentor CRC1/CRC2 staff on basic clinical research concepts, GCP, GDP, SOPs, and related study aspects. Other Coordinate and participate in quality assurance reviews conducted by sponsors, federal agencies, or review groups. Support daily activities of multiple moderately complex trials and perform data management tasks, including chart preparation and program audits. Prepare conference lists for multidisciplinary meetings and participate in site visits; assist with collecting/analyzing data and samples as needed. Perform other related tasks under moderate supervision and contribute to problem solving in assigned studies. Education & Experience Minimum Qualifications : College or university degree in a related field. Work Experience : 2-5 years of related work experience. Qualifications Preferred Qualifications Bachelor’s degree; continuing education such as ACRP, SoCRA or Graham School Clinical Trials. Experience coordinating multiple studies (investigator-initiated, industry-sponsored, multi-site). Management & Regulatory Compliance certification. Knowledge of patient evaluation, clinical trial protocols, GCP, GDP, SOPs, IRB processes, federal regulations, and PHI handling. Strong organizational, communication, and data management skills; ability to handle competing demands with diplomacy; proficient with MS Word/Excel/Adobe Acrobat; familiarity with GCP. Application Documents Resume (required) Cover Letter (required) Posting & Other Details The University of Chicago is an equal opportunity employer and offers a benefits program for eligible employees. All offers are contingent upon a background check. Reasonable accommodations are available; contact the Applicant Inquiry Form for assistance. #J-18808-Ljbffr