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.
Collecting data from oral reports and medical records, data entry, copying/faxing research information, maintaining organized files and records, preparation of manuscripts and PowerPoint presentations.
Performs moderately complex lab and/or research-related duties and tasks.
Collects and maintains data and/or specimens.
Conducts literature reviews.
Assists with preparation of reports, manuscripts and other documents.
Maintains and orders equipment and supplies.
Helps monitor compliance with institutional, state, and federal regulatory policies, procedures, directives and mandates.
May orient or coordinate the work of research support staff and students.
Responsibilities may include the following non-laboratory duties: May assist in recruiting and scheduling research subjects; assisting with developing or amending study protocols; assisting with developing data collection tools; assisting with building databases; and providing general administrative support.
Responsibilities may include the following laboratory duties: setting up and performing experiments; interacting with students and other laboratory staff under the direction of the principal investigator.
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: JR10781
About University of Chicago (UC)
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