Research - Laboratory/Non-Laboratory, Staff/Administrative
Location: Hyde Park Campus
1) Manages all aspects of conducting clinical trials from startup to closeout for one or two clinical trials. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
2) Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
3) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
4) Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, noting severity and causality and attribution of the adverse events; reports findings to PI, sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.
5) Reviews the protocol plan to understand and assist with planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.
6) Organizes and actively participates in site visits from sponsors and other relevant study meetings.
7) Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
8) Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
9) Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
10) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
11) Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant Institutional Review Board (IRB) approvals, source documentation, CRFs, drug dispensing logs, and study related communication.
12) May prepare and maintain protocol submissions and revisions.
1) Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
2) Ability to communicate with tact and diplomacy.
3) Strong organizational skills.
4) Strong communication skills (verbal and written).
5) Excellent interpersonal skills.
6) Strong data management skills and attention to detail.
7) Knowledge of Microsoft Word, Excel and Adobe Acrobat.
8) Ability to read and understand complex documents (e.g., clinical trials).
9) Ability to handle competing demands with diplomacy and enthusiasm.
10) Ability to absorb large amounts of information quickly.
11) Adaptability to changing working situations and work assignments.
12) Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
13) Knowledge of medical terminology / environment.
14) Understanding of the IRB submission and review process and when and how to apply for IRB review.
15) Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.
1) Bachelorâ™s degree
1) 1 year of clinical research experience or relevant experience
1) 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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Internal Number: JR06496
About University of Chicago
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.