Clinical Research Coordinator 2

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 2 (CRC2) 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.

• May assist in the training of new or backup coordinators.

• Responsibilities may include the following non-laboratory duties: may assist in recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support.

• Responsibilities may include the following laboratory duties: setting up and performing experiments; interacting with students and other laboratory staff under the direction of the principal investigator.

• 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.

• Accountable for all tasks in moderately complex clinical studies.

• Facilitates and participates in the daily activities of moderately complex clinical st