Clinical Research Coordinator 2 - Pediatrics

University of Chicago•Chicago, IL

About The Position

The Clinical Research Coordinator 2 (CRC2) provides research support within the University of Chicago Department of Pediatrics. The role works under the general direction of the Director of Clinical Research, a principal investigator (PI), and the study team. The CRC2 supports multiple types of research trials, including national multi-center cooperative group and intergroup studies, multi-institutional pharmaceutical trials, and multi-center trials designed, implemented, and coordinated within a disease-specific Section. The position coordinates moderately complex clinical studies, supporting study activities, regulatory compliance, research data and sample collection, and study documentation. The CRC2 works with a limited to moderate degree of independence and contributes to problem-solving on assigned studies and tasks. The role may also assist with training new or backup coordinators.

Requirements

College or university degree in a related field.
2–5 years of work experience in a related job discipline.
Ability to communicate effectively in writing and orally, follow written and verbal instructions, and comprehend complex technical and clinical documents.
Ability to develop and manage interpersonal relationships and work effectively independently or as part of a team.
Ability to collaborate with faculty and divisional clinical research infrastructure.
Ability to exercise discretion with confidential, sensitive, or stressful matters and handle competing demands with diplomacy.
Ability to respond calmly and rationally to conflicts or emergencies.
Ability to prioritize multiple tasks, manage time efficiently, meet deadlines, and maintain strong organizational skills.
Ability to work independently and learn and develop new skills.
Strong data management skills and attention to detail.
Familiarity with medical terminology and Good Clinical Practices (GCP).
Extensive knowledge of Microsoft Word, Excel, and Adobe Acrobat.
Understanding of federal research regulations and human research protections.
Ability to participate in protocol review and evaluate clinical trials.

Nice To Haves

Bachelor’s degree.
Two years of clinical research experience coordinating multiple types of studies, such as investigator-initiated, industry-sponsored, and multi-site trials.

Responsibilities

Implement and document standard operating procedures in accordance with study sponsor, principal investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies.
Coordinate and potentially participate in quality assurance reviews, including sponsor, federal agency, and specially designated review group site visits, monitoring visits, and audits.
Prepare IRB submissions independently and in a timely manner, and understand the IRB submission and review process, including when and how to apply for review.
Collect, process, ship, and store specimens according to established aseptic techniques and laboratory requirements.
Prepare program conference lists for multidisciplinary conferences and workshops.
Assist in training new or backup coordinators.
Be accountable for tasks in moderately complex clinical studies and assist with professional, organizational, and operational tasks under moderate supervision.
Facilitate and participate in daily activities of moderately complex clinical studies, including patient data retrieval, clinical research record documentation, and participation in program audits.
Coordinate collection of analyzable clinical research data and/or samples with limited to moderate independence.
Contribute to problem-solving on assigned clinical research studies and tasks.
Perform other related work as needed.