Clinical Research Coordinator 3, Trauma Surgery

Department

BSD SUR - Research Services: Clinical Research

About the Department

Since the founding of the Department in 1927, many scientists, including our very own Nobel Prize-winning Charles B. Huggins, MD, have made important discoveries about various diseases and treatment protocols that still serve as a basis for standard clinical practice today. Our scientists continue to embody the ethos of the University of Chicago's commitment to open, rigorous, and intense inquiry. Our laboratories tackle some of today's most complex biomedical challenges, including research into immunotolerance, vaccine stabilization and bioengineering. This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment.

Job Summary

The Clinical Research Coordinator 3 (CRC3) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. Under limited direction of departmental leadership, the CRC3 supports and provides guidance on the administration of the compliance, financial and other related aspects of the clinical study.

Responsibilities

• Manages multiple moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
• Responsibilities include, but are not limited to, recruiting and screening of study subjects, obtaining informed consent, enrolling subjects in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF) and adverse event reports, and ensuring protocol adherence.
• Conducts all sponsor-related visits and acts as a liaison between sponsor and PI.
• Reviews and meets regularly with PI to review study portfolio.
• Participates in study start-up activities.
• Works with the lab team to process and collect samples for internal processing.
• Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
• Collects, processes, ships, and stores specimens to appropriate laboratory according to established aseptic techniques. 
• Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor, and IRB under general direction of clinical research manager.
• Organizes and actively participates in site visits from sponsors and other relevant study meetings. 
• Maintains a safe research environment and ensures compliance with governmental and University policies, procedures, and regulations.
• Trains student and research assistants on basic tasks and skills required for their roles.
• Assists research manager in study start-ups including feasibility, document completion and other start-up activities.
• Assists research manager and PIs in protocol development for IITs.
• Builds RedCAP databases as needed.
• Assists in data use agreements and other contracts involving clinical trials.
• Assists in preparation of abstracts and presentations at conferences.
• Tracks all awards and agreements to ensure they remain active and accurate.
• Assists CRC 1s and CRC2s in their role as needed.
• Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, providing efficient and complete data collection, processing, analysis and reporting; assuring source documentation and data abstraction and entry are being done at the protocol specified time-points; ensuring data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitating the exchange of data across projects and organizations.
• Protects patient and data confidentiality by ensuring security of research data and protected health information (PHI), and compliance with federal regulations and sponsor protocols.
• Ensures standard operating procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
• Works closely with regulatory manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
• Ensures compliance with federal regulations and institutional policies.
• May mentor CRC1 or other CRC2 staff on the basics of clinical research,