Clinical Research Coordinator 2 - JR28160-3800 - The University of Chicago
Chicago, IL
About the Job
This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12299227 Department
BSD MED - Rheumatology
About the Department
The Section of Rheumatology was formed in 1967 when the Divisions of
Metabolism and Rheumatology were combined into one Section with two
Section Chiefs: Drs. Leif Sorensen and Dan McCarty. During this time,
the faculty including Attalah Kappas, M.D. and Rudi Schmid, M.D. made
important contributions to the understanding of several metabolic
diseases. Dr. Sorensen then went on to be the Vice Chair of the
Department of Medicine for 20 years and the Chair in 1997. In 1980, Dr.
Michael Becker became the Section Chief and served until 2000. The
current Section Chief is Marcus Clark, M.D.
Job Summary
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher
partnering with the clinical Principal Investigator (PI) and under the
direction of a departmental or lab research manager. While the Principal
Investigator is primarily responsible for the overall design, conduct,
and management of the clinical trial, the CRC2 supports, facilitates and
coordinates independently the daily clinical trial activities and plays
a critical role in the conduct of the study. By performing these duties
with limited supervision and/or guidance, the CRC2 works with the PI,
department, sponsor, and institution to support and provide guidance on
the administration of the compliance, financial, personnel and other
related aspects of the clinical study.
Responsibilities
- Manages all aspects of conducting clinical trials including:
screening, enrollment, subject follow-up, completion of the case
report form, and adverse event reports.
- Recruit and interview potential study patients with guidance from PI
and other clinical research staff.
- Collect, process, ship and store specimens to appropriate laboratory
according to established aseptic techniques.
- Identify and explain the responsibilities of Principal
Investigators, research team members, sponsors, contract research
organizations (CROs), and regulatory authorities related to the
conduct of a clinical trial.
- Coordinate the conduct of the study from startup through closeout
including recruitment and screening of study subjects, obtaining
informed consent, collecting research data, and ensuring protocol
adherence.
- Plans and coordinates patient schedule for study procedures, return
visits, and study treatment schedules.
- Educates patients about study procedures to be performed, visit
schedule, what to report between and during visits, and the risks
and benefits of the procedures.
- Performs assessments at visits and monitors for adverse events.
- Organizes and attends site visits from sponsors and other relevant
study meetings.
- Protect patients and data confidentiality by ensuring security of
research data and personal health information and compliance with
federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and
documented in accordance to study sponsor, primary investigator, and
regulatory agency specifications.
- Maintains accurate and complete records which may include, but are
not limited to, signed informed consent, relevant IRB approvals,
source documentation, Case Report Forms (CRF's), drug dispensing
logs, and study related communication.
- Understand the IRB submission and review process and when and how to
apply for IRB review, including facilitation of study initiation
through meticulous and timely preparation of IRB submissions
independently.
- Ensures compliance with federal regulations and institutional
policies.
- May prepare and maintain protocol submissions and revisions.
- May assist in the tr ining of new or backup coordinators.
- 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.
- Accountable for all tasks in moderately complex clinical studies.
- 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 related job discipline.
---
Certifications:
---
Preferred Qualifications
Education:
- Bachelors degree.
Experience:
- Clinical research experience or relevant experience.
- Experience coordinating multiple studies (e.g., investigator
initiated, industry sponsored, multi-site trials).
Preferred Competencies
Ability to be aware of safety hazards and take appropriate precautions.
<
information, please see:
https://illinoisjoblink.illinois.gov/jobs/12299227 Department
BSD MED - Rheumatology
About the Department
The Section of Rheumatology was formed in 1967 when the Divisions of
Metabolism and Rheumatology were combined into one Section with two
Section Chiefs: Drs. Leif Sorensen and Dan McCarty. During this time,
the faculty including Attalah Kappas, M.D. and Rudi Schmid, M.D. made
important contributions to the understanding of several metabolic
diseases. Dr. Sorensen then went on to be the Vice Chair of the
Department of Medicine for 20 years and the Chair in 1997. In 1980, Dr.
Michael Becker became the Section Chief and served until 2000. The
current Section Chief is Marcus Clark, M.D.
Job Summary
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher
partnering with the clinical Principal Investigator (PI) and under the
direction of a departmental or lab research manager. While the Principal
Investigator is primarily responsible for the overall design, conduct,
and management of the clinical trial, the CRC2 supports, facilitates and
coordinates independently the daily clinical trial activities and plays
a critical role in the conduct of the study. By performing these duties
with limited supervision and/or guidance, the CRC2 works with the PI,
department, sponsor, and institution to support and provide guidance on
the administration of the compliance, financial, personnel and other
related aspects of the clinical study.
Responsibilities
- Manages all aspects of conducting clinical trials including:
screening, enrollment, subject follow-up, completion of the case
report form, and adverse event reports.
- Recruit and interview potential study patients with guidance from PI
and other clinical research staff.
- Collect, process, ship and store specimens to appropriate laboratory
according to established aseptic techniques.
- Identify and explain the responsibilities of Principal
Investigators, research team members, sponsors, contract research
organizations (CROs), and regulatory authorities related to the
conduct of a clinical trial.
- Coordinate the conduct of the study from startup through closeout
including recruitment and screening of study subjects, obtaining
informed consent, collecting research data, and ensuring protocol
adherence.
- Plans and coordinates patient schedule for study procedures, return
visits, and study treatment schedules.
- Educates patients about study procedures to be performed, visit
schedule, what to report between and during visits, and the risks
and benefits of the procedures.
- Performs assessments at visits and monitors for adverse events.
- Organizes and attends site visits from sponsors and other relevant
study meetings.
- Protect patients and data confidentiality by ensuring security of
research data and personal health information and compliance with
federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and
documented in accordance to study sponsor, primary investigator, and
regulatory agency specifications.
- Maintains accurate and complete records which may include, but are
not limited to, signed informed consent, relevant IRB approvals,
source documentation, Case Report Forms (CRF's), drug dispensing
logs, and study related communication.
- Understand the IRB submission and review process and when and how to
apply for IRB review, including facilitation of study initiation
through meticulous and timely preparation of IRB submissions
independently.
- Ensures compliance with federal regulations and institutional
policies.
- May prepare and maintain protocol submissions and revisions.
- May assist in the tr ining of new or backup coordinators.
- 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.
- Accountable for all tasks in moderately complex clinical studies.
- 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 related job discipline.
---
Certifications:
---
Preferred Qualifications
Education:
- Bachelors degree.
Experience:
- Clinical research experience or relevant experience.
- Experience coordinating multiple studies (e.g., investigator
initiated, industry sponsored, multi-site trials).
Preferred Competencies
Ability to be aware of safety hazards and take appropriate precautions.
<
Source : The University of Chicago
