Clinical Research Coordinator 1
Hyde Park Campus
About the Unit
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.
The Clinical Research Coordinator 1 works under the general direction of a Clinical Research Manager and the Director of Clinical Research.
- Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
- Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
- Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
- Prepares and maintains protocol submissions and revisions.
- Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
- Performs assessments at visits and monitors for adverse events.
- Organizes and attends site visits from sponsors and other relevant study meetings.
- May recruit and interview potential study patients.
- May obtain, possess, and transport specimens to appropriate laboratory according to established aseptic techniques.
- Collecting data from oral reports and medical records, data entry, copying/faxing research information, maintaining organized files and records, preparation of manuscripts and PowerPoint presentations.
- Performs moderately complex lab and/or research-related duties and tasks.
- Collects and maintains data and/or specimens.
- Analyzes data.
- Conducts literature reviews.
- Assists with preparation of reports, manuscripts and other documents.
- Maintains and orders equipment and supplies.
- Helps monitor compliance with institutional, state, and federal regulatory policies, procedures, directives and mandates.
- May orient or coordinate the work of research support staff and students.
- Responsibilities may include the following non-laboratory duties: May assist in recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support.
- Responsibilities may include the following laboratory duties: setting up and performing experiments; interacting with students and other laboratory staff under the direction of the principal investigator.
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
- Ability to communicate with tact and diplomacy required.
- Strong organizational skills required.
- Strong communication skills (verbal and written) required.
- Excellent interpersonal skills required.
- Strong data management skills and attention to detail required.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat required.
- Ability to read and understand complex documents (e.g., clinical trials) required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Ability to absorb large amounts of information quickly required.
- Adaptability to changing working situations and work assignments required.
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred.
- Knowledge of medical terminology / environment preferred.
- Understanding of the IRB submission and review process and when and how to apply for IRB review preferred.
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation preferred.
Education and Experience:
- Bachelor's degree required.
- One year of research experience or relevant experience preferred.
- Knowledge of medical terminology/environment preferred.
- Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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