Manages multiple concurrent moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
Working closely with the Transplant Institute to identify potential patients in all clinics.
Conduct all sponsor-related visits and facilitate as an liaison between sponsor and PI.
Review and meet regularly with PI to review study portfolio.
Facilitate in the planning and identifying the workflow pathway of new clinical trials.
Participate in study start-up activities.
Work closely with Transplant pharmacy to ensure effective workflow and success of trials.
Work with the lab team to process and collect samples for internal processing.
Collect, process, ship and store 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.
Data Management:
Protect 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.
Regulatory Compliance:
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, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study.
Other:
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Analyzes, facilitates and participates in the daily activities o
Benefits
Health insuranceVision insurance
Additional Information
Department
BSD SUR - Research Services: Investigator Initiated Trials
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.
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 2 (CRC2) is a specialized researcher working with the Principal Investigator (PI), Co-Investigator(s) and other study personnel, and under the direction of departmental, clinical research manager. With limited supervision and/or guidance, the CRC2 works with the PI, Co- Investigator(s), department, and sponsoring agencies to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.
Uchicago · Chicago, IL