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

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Clinical Research Coordinator I

Seeking Breakthrough Makers

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

A Brief Overview

The Infectious Diseases Epidemiology and Antimicrobial Stewardship (IDEAS) Research Group is seeking an energetic, organized, detail-oriented candidate who enjoys a fast-paced environment to support two Principal Investigators with a focus on infectious disease and oncology/cellular therapy patients. 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. This individual will contribute to clinical research within the Center for Childhood Cancer Research (CCCR).

This role functions independently in a clinical research setting and is responsible for the complete coordination of specific clinical research projects, including clinical trials, observational and data studies. Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols. Duties involve managing the day-to-day activities of the research study under the guidance of PI or managing study staff. This individual should have an interest in research related to the microbiome, infectious diseases, and viral illness in oncology patients malignant and non-malignant transplant patients. This individual will perform all clinical research coordinator responsibilities, as detailed in the job responsibilities, working in collaboration with disease specific groups within the CCCR, including the Supportive Care in Oncology Research Program (SCORe).

Dr. Fisher is an attending physician in the Division of Infectious Diseases at CHOP and an Associate Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. Dr. Fisher's research focuses on infections in children with immunocompromising conditions. He currently serves as the chair of the Infectious Disease Committee of the Children's Oncology Group and co-director of the International Pediatric Fungal Network. In these positions he helps design and perform large multicenter observational studies and randomized controlled trials in immunocompromised patient populations-specifically in children with leukemia and those undergoing hematopoietic stem cell transplantation. Dr. Fisher also serves as the Associate Chair of Research for the Department of Pediatrics.

Dr. Elgarten is an attending physician in the Division of Oncology, Cellular Therapy and Transplant Section at CHOP, Director of the SCORe; a core faculty member in Clinical Futures, a Research Center of Emphasis at CHOP. Her research is focused on improving outcomes for pediatric patients with high risk hematologic malignancies and those who require stem cell transplant.

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
• Facilitate study close out activities as appropriate
• Coordinate research/project team meetings
• Collect, process and ship samples as applicable to the protocol
• Schedule subject visits and procedures
• Retain records/archive documents after study close out

Education Qualifications

• High School Diploma / GED Required
• Bachelor's Degree Preferred

Experience Qualifications

• At least two (2) years of clinical or clinical related or research related experience Required
• At least three (3) years of clinical or clinical related or research related experience Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection
• Strong verbal and written communications skills
• Strong time management skills
• Ability to collaborate with stakeholders at all levels

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine. Learn more.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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