Clinical Research Coordinator 2, Oncology & Multi-Site Trials
Overview
You will own the day-to-day execution of 2-5 moderately complex clinical trials, including national and multi-institutional pharmaceutical studies, at the University of Chicago's Department of Surgery. You will work directly with the Principal Investigator and sponsor liaisons, managing subject recruitment, data integrity, and regulatory compliance from start-up to closeout. You will coordinate with a dedicated lab team for specimen processing and ensure protocol adherence across all sites. This role stands out for its depth in GCP and IRB compliance, with opportunities to mentor junior coordinators.
What You'll Do9
- 1Recruit, screen, and enroll study subjects, obtaining informed consent and conducting follow-up visits to ensure protocol adherence.
- 2Manage study start-up activities, including preparing and submitting IRB approvals, and coordinating sponsor-initiated site visits.
- 3Collect, process, ship, and store specimens to designated labs using aseptic techniques, ensuring chain-of-custody documentation.
- 4Execute data management tasks, including case report form (CRF) completion, source data abstraction, and query resolution within sponsor timelines.
- 5Monitor subjects for adverse events and protocol deviations, documenting findings and escalating to the PI, sponsor, and IRB as required.
- 6Facilitate sponsor monitoring visits and audits, serving as the primary liaison between the sponsor and the research team.
- 7Maintain regulatory files, including signed informed consent, IRB approvals, and study communications, ensuring compliance with federal regulations.
- 8Train and mentor CRC1 staff on GCP, GDP, and SOPs to build team capability.
- 9Assist in protocol development and feasibility assessments for new investigator-initiated trials.
Requirements9
- 12-5 years of clinical research coordination experience, including managing IRB submissions and GCP compliance.
- 2Bachelor's degree in a relevant field; ACRP or SoCRA certification preferred.
- 3Experience coordinating multiple trials (e.g., investigator-initiated, industry-sponsored, or multi-site).
- 4Knowledge of medical terminology and patient assessment procedures across diverse therapeutic areas.
- 5Proficiency in Microsoft Word, Excel, and Adobe Acrobat for study documentation and data tracking.
- 6Strong data management skills with attention to detail in protocol data collection and query resolution.
- 7Ability to interpret and implement clinical trial protocols, including safety reporting requirements.
- 8Understanding of federal research regulations and institutional policies governing human subjects research.
- 9Excellent communication and interpersonal skills to interact with patients, sponsors, and interdisciplinary teams.
Salary Insight
$60 - $75k per year
Location
Required Skills
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