Manages all aspects of conducting clinical trials and clinical research studies 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.
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.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.
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.
Organizes and actively participates in site visits from sponsors and other relevant study meetings.
Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
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.
Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.
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.
Bachelor's Degree in a related field.
Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.
Strong organizational skills.
Strong communication skills (verbal and written).
Excellent interpersonal skills.
Strong data management skills and attention to detail.
Ability to read and understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.
Knowledge of medical terminology.
Understanding of the IRB submission and review process and when and how to apply for IRB review.
Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.
Cover Letter (required)
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Internal Number: JR10172
About University of Chicago (UC)
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