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.
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.
Understand the federal research regulations and identify the federal research organizationsâ™ role in regulating human research participation.
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Participates in 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.
One year of research experience or relevant experience.
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 read and 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.
Cover Letter (required)
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Internal Number: JR10569
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.