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https://illinoisjoblink.illinois.gov/jobs/11843035 Department
BSD MED - Gastroenterology - Clinical Research Staff
About the Department
The Section of Gastroenterology, Hepatology at The University of Chicago
is consistently ranked among the best specialty nationally by U.S News
and World Report. With nearly 30 specialists on staff, our program plays
a leading role in the understanding of digestive diseases and in
developing innovative and successful treatments for patients. Since
forming the nation\'s first full-time department of gastroenterology in
1927, our physicians have continually improved treatments for digestive
tract and related disorders by combining medical research, education,
and patient care at the highest level.
Job Summary
The Senior Clinical Research Coordinator (Sr. CRC) is a specialized
researcher partnering with the clinical Principal Investigator (PI) and
under the direction of the Clinical Research Manager within the Section
of Gastroenterology in the Department of Medicine. While the Principal
Investigator is primarily responsible for the overall design, conduct,
and management of the clinical trial, the Sr. CRC oversees, facilitates
and coordinates the daily activities of complex clinical trials and
plays a critical role in the conduct of the studies to ensure compliance
with federal and institutional regulations.
Responsibilities
- Leads within the department/unit through improving clinical research
practice and serves as a resource to others.
- 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
studies.
- Assists with or plans and implements the clinical study\'s goals and
objectives; organizes patient enrollment planning; conducts quality
assurance activities, compiles and analyzes data.
- Acts as a liaison with medical staff, University departments,
ancillary departments and/or satellite facilities.
- Serves as a resource person or acts as a consultant within area of
clinical expertise.
- Acts as a leader within the department/unit through improving
clinical research practice and serving as a resource.
- Maintains working knowledge of current protocols, and internal SOPs.
- Accountable for high standards of clinical research practice and
assists in the development of accountability in others.
- Develops and implements procedures, maintains records, tracks
progress, and conducts quality assurance on data collected.
- Oversees and participates in the coordination and conduct of complex
clinical research studies and ensures compliance with federal and
institutional regulations.
- Prepares, submits, and assists Investigators with multiple levels of
research documentation (i.e. IRB submissions, educational materials,
reports, grant renewal reports, and study forms).
- Provides Investigators with guidance regarding protocol
requirements.
- Maintains regulatory documentation.
- Assists other research personnel with reports to regulatory
agencies, such as the IRB, FDA and Data and Safety Review Committee.
- Prepares for and assists with audits, inspections, and monitoring
visits from regulatory agencies or sponsors.
- Provides direct supervision of other CRC staff (i.e. hiring/firing,
performance evaluations, disciplinary actions, approve time off,
etc.), or assist.
- Attends continuing education and training opportunities relevant to
job duties.
- Solves complex problems relating to data management and the analysis
of large administrative datasets. Works independently to develop,
manage, and report on key data and ensures timeliness of data and
re orting submissions from multiple investigators.
- Acts as a resource on the basics of clinical research and related
aspects of clinical study for colleagues with less experience.
Prepares and evaluates writing protocols, IRB submissions, grant
applications, manuscripts, reports, and dissemination tools.
- 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 5-7
years of work experience in a related job discipline.
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Certifications:
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Preferred Qualifications
Experience:
- Clinical research experience coordinating multiple and variety of
studies (e.g., investigator initiated; industry sponsored;
multi-site trials).
Preferred Competencies
Aware of safety hazards and take appropriate precautions.
Communicate in writing.
Communicate orally.
Comprehend technical documents.
Condense complicated issues t