Clinical Research Coordinator 1 Pediatrics

University of Chicago • Chicago, IL

270d • $50,000 - $65,000

About The Position

The Pediatric Clinical Research Coordinator 1 provides support to the Section of Pediatric Gastroenterology. The CRC1 will be involved in coordinating all aspects of studies under the supervision of a PI. The Clinical Research Coordinator 1 works under the direction of Dr. Ritu Verma, Dr. Amelia Kellar, and other PIs in the Section, and the leadership within the Pediatric Clinical Trials Office. The CRC1 will be involved in multiple research trial types: biobanking, registry, observational, and multi-institutional pharmaceutical trials implemented and coordinated in the Section. Clinical research tasks may also include study concept development, protocol development and writing, study administration and data collection for an investigator-initiated trial and other new research projects developed by the PIs.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Nice To Haves

• Bachelor's degree.
• 1-year clinical research experience or relevant experience.

Responsibilities

• Aliquot and prepare experimental and clinical samples for freezing.
• Ensures accurate storage for all specimen types, including blood and plasma samples.
• Coordinates 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.
• Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), and study-related communication.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Perform experiments, collect, analyze, and interpret data under the supervision of the PI or designee.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance with study sponsor, primary investigator, and regulatory agency specifications.
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• 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.
• Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• May prepare and maintain protocol submissions and revisions.
• May assist in the training of new or backup coordinators.
• Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.
• 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.
• Assists with various professional, organizational, and operational tasks under direct supervision.
• Supports quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• Performs other related work as needed.

Benefits

• The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Educational Services
• Education Level: Bachelor's degree