- 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.
- Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
- Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Performs other related work as needed.
- Bachelor's degree.
- Knowledge of medical terminology/environment.
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
- Ability to communicate with tact and diplomacy.
- Strong organizational skills.
- Strong communication skills (verbal and written).
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat.
- Ability to understand complex documents (e.g., clinical trials).
- Ability to handle competing demands with diplomacy and enthusiasm.
- Ability to absorb large amounts of information quickly.
- Adaptability to changing working situations and work assignments.
- Resume (required)
- Cover Letter (required)
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clinical research coordinator 1 - , IL, United States - University of Chicago
Description
DepartmentBSD 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 Clinical Research Coordinator 1 provides support to the faculty of the Section of Gastroenterology within the Biological Sciences Division.
Education:
Minimum requirements include a college or university degree in related field.
* Work
Experience:
Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.
* Certifications:* Preferred Qualifications
Education:
Experience:
When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.
Research
Role Impact
Individual Contributor
FLSA Status
Exempt
Pay Frequency
Monthly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call or submit a request via Applicant Inquiry Form.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
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.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information.
The Report can be accessed online at:
Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.