Clinical Research Coordinator - Pediatric Infectious Diseases Epidemiology and Antimicrobial Stewardship (IDEAS)

SHIFT:

Any (United States of America)

Clinical Research Coordinator I

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We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.


A Brief Overview

The successful candidate will join the research teams of Dr. Jeffrey Gerber and Dr. Kathleen Chiotos in the Pediatric Infectious Diseases Epidemiology and Antimicrobial Stewardship (IDEAS) Research Group at Children’s Hospital of Philadelphia (CHOP). The clinical research coordinator’s primary responsibilities will be to assist in the enrollment of children from the CHOP Primary Care Network in a large clinical trial. Availability on evenings and weekends may be required on a rotating basis.

Dr. Gerber is an attending physician in the Division of Infectious Diseases at CHOP and Professor of Pediatrics and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania. His research focuses on the epidemiology and outcomes of antimicrobial use in children with the goal of improving clinical outcomes while limiting the emergence of antimicrobial resistance. Dr. Chiotos is an attending physician in the pediatric intensive care unit (PICU) at CHOP, and Assistant Professor of Anesthesiology and Critical Care at the Perelman School of Medicine at the University of Pennsylvania with a secondary appointment in pediatric infectious diseases. Dr. Chiotos’s research interests are related to the epidemiology and treatment of multidrug resistant gram-negative infections as well as antimicrobial stewardship in the PICU setting.

The applicant is expected to work comfortably as part of a research team. The successful applicant should have strong writing, organizational, and analytical skills. Job responsibilities may include participation in grant writing, protocol development, study implementation, study management, data analysis, oral presentation and manuscript presentation. The coordinator will be responsible for leading specific projects, and a collaborative working style is required.

The candidate will be a member of the Pediatric IDEAS Research Group, a collaborative group of investigators within Clinical Futures at CHOP. The mission of the Pediatric IDEAS Research Group is to perform rigorous clinical and translational research that generates evidence on the prevention and treatment of infections to inform best practices and improve the health of children, families, and communities.

What you will do

• Core responsibilities
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Under the supervision of PI Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials
• Must comply with federal, state, and sponsor policies
• For multi-site studies or collaborations, support communication and meeting scheduling across teams
• Related responsibilities
• Manage essential regulatory documents
• Register study on ClinicalTrials.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)
• Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate
• Facil