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https://illinoisjoblink.illinois.gov/jobs/11880033 Department
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