Clinical Research Coordinator II - Gastroenterology

Department

BSD MED
- Gastroenterology
- Clinical Research Staff

The Section of Gastroenterology, Hepatology at The University of Chicago is consistently ranked among the best specialties 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.

The Clinical Research Coordinator II (CRCII) is a specialized researcher who partners with the clinical Principal Investigator (PI) and works under the direction of the Clinical Research Manager in the Section of Gastroenterology in the Department of Medicine.

• 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 the PI and other clinical research staff.
• Collects, processes, ships, and stores specimens to appropriate laboratory using 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, obtaining informed consent, collecting research data, and ensuring protocol adherence.
• Plans and coordinates patient schedules for study procedures, return visits, and study treatment schedules.
• Educates patients about study procedures, visit schedules, 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 with study sponsor, primary investigator, and regulatory agency specifications.
• Maintains accurate and complete records, including signed informed consent, relevant IRB approvals, source documentation, case report forms, drug dispensing logs, and study‑related communication.
• Understands the IRB submission and review process and facilitates 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.
• Assists in training 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.
• Solves a range of straightforward problems related to the administration of the compliance, financial, and other aspects of a clinical study.
• Facilitates and participates in the daily activities of moderately complex clinical studies, performing patient data retrieval, documenting clinical research records, and participating in program audits.
• Accountable for all tasks in moderately complex clinical studies.
• Performs other related work as needed.

• Education:
  
  Minimum requirements include a college or university degree in a related field.
• Work Experience:
  
  Minimum requirements include knowledge and skills developed through 2‑5 years of work experience in a related job discipline.

• Bachelor’s degree.

• Clinical research experience or relevant experience.
• Coordinating multiple studies, such as investigator‑initiated, industry‑sponsored, and multi‑site trials.

• Aware of safety…