Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruit and interview potential study patients with guidance from PI and other clinical research staff.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
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.
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.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
Performs assessments at visits and monitors for adverse events.
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 independently.
Ensures compliance with federal regulations and institutional policies.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
Analyzes 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.
2 years of clinical research experience or relevant experience.
Ability to be aware of safety hazards and take appropriate precautions.
Ability to communicate in writing.
Ability to communicate orally.
Ability to comprehend technical documents.
Ability to condense complicated issues to simple summaries that can be understood by a variety of constituents.
Ability to create and deliver presentations.
Ability to develop and manage interpersonal relationships.
Ability to exercise absolute discretion regarding confidential matters.
Ability to follow written and/or verbal instructions.
Ability to give directions.
Ability to handle sensitive matters with tact and discretion.
Ability to handle stressful situations.
Ability to learn and develop skills.
Ability to maintain a high level of alertness.
Ability to pay attention to detail.
Ability to perform multiple tasks simultaneously.
Ability to prioritize work and meet deadlines.
Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
Ability to read.
Ability to train or teach others.
Ability to work effectively and collegially with little supervision or as member of a team.
Ability to work independently.
Cover Letter (required)
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Internal Number: JR10081
About University of Chicago (UC)
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