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

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Clinical Research Coordinator II

Seeking Breakthrough Makers

Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means.

A Brief Overview

The successful candidate will join the research team of Dr. Kevin Downes in the Pediatric Infectious Diseases Epidemiology and Antimicrobial Stewardship (IDEAS) Research Group at Children's Hospital of Philadelphia (CHOP). Dr. Downes is an attending physician in the Division of Infectious Diseases at CHOP, Program Director of the CHOP Clinical Pharmacology T32 fellowship program, and an Assistant Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. Dr. Downes's research focuses on antibiotic use in children and the medical management of children with infectious diseases. Specifically, his research interests include antimicrobial pharmacokinetics/pharmacodynamics (PK/PD) and antibiotic-associated toxicities. Dr. Downes's research explores methods to promote individualized dose optimization of antimicrobials in children and examines the roles of biomarkers in the management of children with infectious diseases. He currently serves as the site PI and/or co-investigator for various clinical trials being conducted at CHOP, as well as the PI for several ongoing prospective observational studies.

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. The candidate will also be a member of Center for Clinical Pharmacology, which is focused on research that improves the safety and efficacy of therapeutics in children. The ideal candidate would be comfortable interacting with the families and medical teams of CHOP patients and processing biospecimens. The role requires work to be performed on-site at CHOP's Philadelphia campus and flexibility to shift responsibilities and work hours to meet the needs of the group's studies. Evening and weekend coverage is not required, but could be available.

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
• 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
• Must comply with federal, state, and sponsor policies
• Related responsibilities
• Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role
• Register study on ClinicalTrial.gov as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• 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 laboratory specimens
• Schedule subject visits and procedures
• Retain records/archive documents after study close out
• Additional Responsibilities may include
• Manage study finances including sponsor invoicing & resolving study subject billing issues
• Develop advertisement materials
• Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
• Organize and/or run study-related meetings locally or across teams (for multi-site projects)
• Support study team communications and outreach
• Provide training to junior staff on conduct of research studies
• Document investigational product (drug/device) accountability
• Self-monitor and self-audit responsibilities
• Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals
• Maintain Clinical Trial.gov
• Develop Case Report Forms
• Assignments to include more complex studies

Education Qualifications

• Bachelor's Degree - Required
• Master's Degree in a related field - Preferred

Experience Qualifications

• At least two (2) years of clinical/research coordination experience - Required
• At least three (3) years of clinical/research coordination experience - Preferred

Skills and Abilities

• Basic knowledge of IRB and human subject protection
• Excellent 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 receive an annual influenza vaccine. Learn more.

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SALARY RANGE:

Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly.

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At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.