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Ann & Robert H. Lurie Children’s Hospital of Chicago

Pediatric healthcare provider and teaching partner

Clinical Research Coordinator 3 - Advanced Therapeutics Initiative

Clinical Research OperationsPosted on Nov 9
Full-timeChicago, IL, USA$59.3k - $96.9kIn-person

About the Job

Requirements

  • A bachelor's degree and at least two years of research experience are required.
  • Strong organizational skills and the ability to manage multiple simultaneous studies are required.
  • Strong verbal and written communication skills are required.
  • Strong knowledge of FDA, HSR, and GCP guidelines is required.
  • Strong analytical skills, including the ability to recognize quantitative and qualitative research methods and adapt to various technological systems, are required.
  • Leadership skills, including the ability to prioritize tasks, solve problems, mentor, and foster an inclusive environment where team members feel valued and respected, are required.

Responsibilities

  • Coordinate and oversee all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
  • Oversee site visits, address sponsor queries promptly, and ensure adherence to study protocols and regulatory requirements throughout study activities.
  • Manage regulatory compliance and documentation, including preparing and maintaining regulatory documents, registering studies on ClinicalTrials.gov when required, assisting investigators with regulatory submissions such as FDA submissions, and developing and updating standard operating procedures to ensure adherence to research protocols and regulatory standards.
  • Promote ethical research conduct and ensure integrity in study conduct and data handling.
  • Manage logistical and administrative aspects of clinical research projects by maintaining supplies and equipment inventory, preparing lab kits and requisitions, organizing and maintaining study documents including regulatory binders and source documents, tracking grant and deliverable deadlines, and constructing codebooks for data dictionaries.
  • Manage participant engagement by identifying and recruiting eligible subjects, conducting informed consent and assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary contact for study-related inquiries and support.
  • Manage the clinical research data lifecycle by abstracting information from medical records, entering data into case report and study forms, preparing abstracted and coded data for analysis, conducting statistical analyses, and ensuring database validity and integrity through quality assurance and quality control checks and data monitoring.
  • Assist with budget preparation and fund review, and support research central offices and the Principal Investigator in grant preparation and reporting.
  • Train and mentor research personnel, assist with study-conduct training, serve as a resource, and assist with onboarding new study team members.
  • Lead dissemination of research findings through manuscript preparation, collaboration on abstracts and posters, presentation of research at national meetings, or coordination of research education conferences.
  • Perform other job functions as assigned.

Desired Qualifications

  • Two to three years of experience with complex research projects is preferred.
  • May assist with technology system implementation.

About the Company

Ann & Robert H. Lurie Children’s Hospital of Chicago

Pediatric healthcare provider and teaching partner

Ann & Robert H. Lurie Children’s Hospital of Chicago is a leading pediatric hospital and teaching hospital, providing comprehensive medical care for children across specialties. It operates as the region’s largest pediatric healthcare provider, offering hospital-based care and serving as a teaching and research partner with Northwestern University Feinberg School of Medicine. Its services are delivered through pediatric clinicians and researchers who diagnose, treat, and manage a wide range of childhood conditions, often incorporating education and clinical research into care. The hospital differentiates itself by its size in the region, its strong academic affiliation, and national rankings across all 10 pediatric specialties by U.S. News & World Report. Its goal is to improve child health by delivering high-quality care, advancing medical knowledge through research, and training the next generation of pediatric clinicians.

Company size
5,001-10,000
Company stage
Grant
Total funding
$10M
Headquarters
Chicago, IL
Founded
1900

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