Clinical Research Coordinator 2 - Pediatrics

University of Chicago•Chicago, IL

3d•Onsite

About The Position

The Clinical Research Coordinator (CRC2) in Pediatrics provides research support within the Department of Pediatrics. The CRC 2 works under the general direction of the Director of Clinical Research, a principal investigator (PI), and the study team. The CRC 2 will be involved in multiple research trial types: multi-centered cooperative group and intergroup studies at a national level, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in a disease-specific Section.

Requirements

Minimum requirements include a college or university degree in related field.
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
Ability to communicate in writing and orally; follow written and verbal instructions; comprehend and read complex technical and clinical documents.
Ability to develop and manage interpersonal relationships; work effectively, independently, or as part of a team; collaborate with faculty and divisional clinical research infrastructure; demonstrate excellent interpersonal skills.
Ability to exercise absolute discretion regarding confidential matters, sensitive, or stressful matters; handle competing demands with diplomacy and enthusiasm; maintain high alertness and respond calmly and rationally to conflicts or emergencies.
Ability to prioritize multiple tasks, manage time efficiently, meet deadlines, and maintain strong organizational skills; work independently; 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.
2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator-initiated; industry-sponsored; multi-site trials).

Responsibilities

Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications, ensuring compliance with federal regulations and institutional policies.
Coordinates and may participate in quality assurance reviews, including site visits, monitoring visits, and audits conducted by study sponsors, federal agencies, or specially designated review groups.
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.
Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
Prepares program conference lists for multidisciplinary conferences and workshops.
May assist in the training of new or backup coordinators.
Accountable for all tasks in moderately complex clinical studies.
Assists with various professional, organizational, and operational tasks under moderate supervision.
Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence.
Contributes to the problem solving on assigned clinical research studies and tasks.
Performs other related work as needed.