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BSD SUR - Transplant Surgery: 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.

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.

Responsibilities

Research Conduct/Study Management:

• Manages multiple concurrent moderately complex clinical trials that may include national level and multi-institutional pharmaceutical.
• Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
• 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.
• 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.
• 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:

• 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, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
• 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 speciall