Clinical Research Coordinator 1
University of ChicagoAbout the role
Department
About the Department
Job Summary
The CRC1 supports, facilitates, and coordinates daily research study activities and plays a critical role in the conduct of the clinical research conducted at the HAARC Center. Primary responsibilities include screening participants for study eligibility, scheduling participant visits, completing participant visits and associated tasks which may include data entry and neuropsychological test administration and scoring. The CRC1 may assist with training and oversight of Research Assistants.
Our Center uses a community-engaged research approach, which actively involves members of the community in the research process. This CRC will work with our Community Engagement team to support engagement, recruitment, and retention to elevate the scientifically rigorous and socially relevant research we conduct.
Responsibilities
Manages all aspects of conducting clinical research including screening, enrollment, participant follow-up, completion of the case report forms, and adverse event reports.
Functions as the point person for participant visits and data collection, including coordinating and monitoring data collection, leading the research assistants in participant scheduling, and implementing protocol updates and changes.
May train research assistants and interns in neuropsychological testing on study related procedures and supervises day-to-day data collection activities.
Completes participant visits and associated tasks, including neuropsychological test administration and scoring, data entry, participant recruitment and/or scheduling.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Educates participants about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
Protect participants 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 with study sponsor, primary investigator, and regulatory 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), and study-related communications.
Plays a critical role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines, and in accordance with Good Clinical Practice (GCP).
Prepares for 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.
Accountable for all tasks in basic clinical studies.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.---
Work Experience:
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Certifications:
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