University of Chicago
Clinical Research Coordinator 1, Islet Lab
University of Chicago, Chicago, Illinois, United States, 60290
Clinical Research Coordinator 1, Islet Lab
Join the University of Chicago’s Islet Lab as a Clinical Research Coordinator 1.
Job Summary This position performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted within the Islet Lab.
Responsibilities
Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. 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 the 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.
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.
Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Provides efficient and complete data collection, processing, analysis and reporting; ensures 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; facilitates 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.
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 basic clinical studies.
Assists with various professional, organizational, and operational tasks under direct supervision.
Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
Performs other related work as needed.
Education Minimum requirements: college or university degree in related field.
Preferred Qualifications
Bachelor's degree in a related field.
Technical Skills or Knowledge
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
Knowledge of medical terminology.
Understanding of the IRB submission and review process and when and how to apply for IRB review.
Understanding of the federal research regulations and the ability to identify the federal research organization’s role in regulating human research participation.
Preferred Competencies
Interact and communicate with clarity, tact, and courtesy with patients, staff, faculty, students, and others.
Strong organizational skills.
Strong communication skills, verbal and written.
Strong data management skills and attention to detail.
Read and understand complex documents.
Handle competing demands.
Application Documents
Resume/CV (required)
Cover Letter (required)
When applying, the documents must be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Details Scheduled Weekly Hours: 40
Drug Test Required: Yes
Health Screen Required: Yes
Motor Vehicle Record Inquiry Required: No
Pay Rate Type: Salary
FLSA Status: Exempt
Pay Range: $50,000.00 - $65,000.00
Benefits Eligible Yes
University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call 773‑702‑5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case‑by‑case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
Seniority Level Entry level
Employment Type Other
Job Function Research, Analyst, and Information Technology
Industry Higher Education
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Job Summary This position performs routine assignments related to the documentation, analysis, and reporting of research data. Provides input to support the strategic, administrative, operational, and financial decisions that impact clinical research conducted within the Islet Lab.
Responsibilities
Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. 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 the 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.
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.
Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Provides efficient and complete data collection, processing, analysis and reporting; ensures 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; facilitates 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.
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 basic clinical studies.
Assists with various professional, organizational, and operational tasks under direct supervision.
Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
Performs other related work as needed.
Education Minimum requirements: college or university degree in related field.
Preferred Qualifications
Bachelor's degree in a related field.
Technical Skills or Knowledge
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
Knowledge of medical terminology.
Understanding of the IRB submission and review process and when and how to apply for IRB review.
Understanding of the federal research regulations and the ability to identify the federal research organization’s role in regulating human research participation.
Preferred Competencies
Interact and communicate with clarity, tact, and courtesy with patients, staff, faculty, students, and others.
Strong organizational skills.
Strong communication skills, verbal and written.
Strong data management skills and attention to detail.
Read and understand complex documents.
Handle competing demands.
Application Documents
Resume/CV (required)
Cover Letter (required)
When applying, the documents must be uploaded via the My Experience page, in the section titled Application Documents of the application.
Job Details Scheduled Weekly Hours: 40
Drug Test Required: Yes
Health Screen Required: Yes
Motor Vehicle Record Inquiry Required: No
Pay Rate Type: Salary
FLSA Status: Exempt
Pay Range: $50,000.00 - $65,000.00
Benefits Eligible Yes
University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination. Job seekers in need of a reasonable accommodation to complete the application process should call 773‑702‑5800 or submit a request via Applicant Inquiry Form. All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case‑by‑case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
Seniority Level Entry level
Employment Type Other
Job Function Research, Analyst, and Information Technology
Industry Higher Education
Referrals increase your chances of interviewing at University of Chicago by 2x.
#J-18808-Ljbffr