The University of Chicago
Clinical Research Coordinator 2, Islet Lab
The University of Chicago, Chicago, Illinois, United States, 60290
This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/12309535 Department
BSD SUR - Transplant Surgery: Research - Islet Lab
About the Department
The Section of Transplantation is built on a strong history of surgical excellence, including the first-ever animal organ transplant in 1904. Over the years, the section has gone on to achieve many more \'firsts,\' including the first successful living donor liver transplant and the first heart-liver-kidney transplant in the world. Today, UChicago Medicine is home to one of the busiest organ transplant centers in the nation and offers more transplant options than any other program in Illinois. What our surgeons can achieve in the operating room would not be possible without the ongoing work that is done in our laboratories, and this is especially true in the Section of Transplantation. Our researchers are well known for their basic science research in transplantation tolerance and clinical trial work around islet cell transplantation for diabetes.
Job Summary
The job compiles, documents, analyzes, and reports on moderately complex clinical studies for the Islet Lab under the direction of Dr. Piotr Witkowski. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.
Responsibilities
Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout. 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.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.Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.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 O erating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.Accountable for all tasks in moderately complex clinical studies.Assists with various professional, organizational, and operational tasks under moderate supervision.Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
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Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a
BSD SUR - Transplant Surgery: Research - Islet Lab
About the Department
The Section of Transplantation is built on a strong history of surgical excellence, including the first-ever animal organ transplant in 1904. Over the years, the section has gone on to achieve many more \'firsts,\' including the first successful living donor liver transplant and the first heart-liver-kidney transplant in the world. Today, UChicago Medicine is home to one of the busiest organ transplant centers in the nation and offers more transplant options than any other program in Illinois. What our surgeons can achieve in the operating room would not be possible without the ongoing work that is done in our laboratories, and this is especially true in the Section of Transplantation. Our researchers are well known for their basic science research in transplantation tolerance and clinical trial work around islet cell transplantation for diabetes.
Job Summary
The job compiles, documents, analyzes, and reports on moderately complex clinical studies for the Islet Lab under the direction of Dr. Piotr Witkowski. Provides input to support the administrative and operational decisions that impact clinical research conducted across the University.
Responsibilities
Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout. 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.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.Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.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 O erating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.Accountable for all tasks in moderately complex clinical studies.Assists with various professional, organizational, and operational tasks under moderate supervision.Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
---
Work Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a