1) Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
2) Recruit and interview potential study patients with guidance from PIs and other clinical research staff.
3) 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.
4) 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.
5) Educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
6) Perform assessments at visits and monitors for adverse events.
7)Organize and attends relevant study meetings.
8) Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and potential sponsor protocols.
9) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
10) 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), and study related communication.
11) 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.
12) Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation.
13) May prepare and maintain protocol submissions and revisions.
14) Trains and oversees the work of research support personnel, such as RAâ™s.
15) Conducts literature reviews.
16) Conducts data collection and uses the electronic health record to identify and record data elements related to our research.
17) Participates in writing reports and manuscripts.
18) Prepare data summaries and reports, and analyze data.
1) Strong organizational skills
2) Ability to communicate with tact and diplomacy
3) Strong communication skills (verbal and written)
4) Excellent interpersonal skills
5) Strong data management skills and attention to detail
6) Knowledge of Microsoft Word, Excel and Adobe Acrobat
7) Ability to read and understand complex documents
8) Ability to handle competing demands with diplomacy and enthusiasm
1)One year of research experience or relevant experience
2)Knowledge of medical terminology/environment
2) Cover letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
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Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via the Applicant Inquiry Form.
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About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.