Clinical Research Coordinator 1 - Pediatrics

University of Chicago-posted 2 months ago
$50,000 - $65,000/Yr
Full-time • Entry Level
Chicago, IL
5,001-10,000 employees
Educational Services
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The Clinical Research Coordinator (CRC) 1 in Pediatrics provides support to the section of Infectious Disease within the Department of Pediatrics. The Clinical Research Coordinator 1 works under the general direction of the Director of Clinical Research, the PI, and the study team. The CRC 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 the Section with their primary responsibility coordinating vaccine clinical trials.

  • Aliquot and prepares 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.
  • Recruits and interviews 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.
  • Performs experiments; collects, analyzes, and interprets 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.
  • Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  • Understands 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.
  • Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
  • Assists with preparation and attends intervention sessions.
  • 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.
  • Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
  • Performs other related work as needed.
  • 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.
  • Bachelor's degree.
  • 1-year clinical research experience or relevant experience.
  • Knowledge of Microsoft Word, Excel, and Adobe Acrobat.
  • Read and understand complex documents (e.g., clinical trials).
  • The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off.
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