Clinical Research Coordinator - Critical Care Medicine

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Clinical Research Coordinator I

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's Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

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

A Brief Overview

Children's Hospital of Philadelphia is hiring in the LUng iNjury Group (LUNG), a sub-section of Critical Care Medicine. The LUNG team is under the direction of Dr. Nadir Yehya, who also serves as the Associate Chief of Research within the division of Critical Care Medicine. We have over 10 ongoing clinical research studies, in different phases, that cover various areas of interest: biomarkers, QA/QI, medical device, protocolized treatment of pediatric ARDS, etc... Our Principal Investigators (Pl) are dedicated to improving the survival outcomes, quality of life, and care of children and young adults within the critical care setting. The PIs are joined with a team of clinical research coordinators, clinical research assistants, lab scientists and techs, clinical nurses, nurse practitioners, and other ancillary team members. Our group aims to grow our clinical research further, both within the Children's Hospital of Philadelphia, but also collaboratively with institutions through the US and internationally. We are hiring a Clinical Research Coordinator to support a lung injury interventional trial. This role functions autonomously in the clinical research setting and is responsible for the management of specific research project(s). Specific responsibilities include but are not limited to: 1) screening for eligible subjects, 2) recruiting and consenting families, 3) coordinating with clinical staff to facilitate study procedures,4) maintaining subject tracking system, 5) conducting chart reviews and abstracting clinical data, 6) performing data quality checks, 7) meticulous record-keeping and documentation for reporting, 8) oversight and adherence to the IRB-approved protocol.

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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