Clinical Research Coordinator I - Critical Care Medicine

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A Brief Overview
Children's Hospital of Philadelphia is hiring in the LUng iNjury Group (LUNG), a program within 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, respiratory therapists, and other ancillary team members. Our program aims to grow our clinical research, both within the Children's Hospital of Philadelphia, and collaboratively with institutions through the US and internationally. We are hiring a Clinical Research Coordinator to support various projects, namely a lung injury interventional trial and other observational studies. 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) data entry and performing data quality checks, 7) meticulous record-keeping and documentation for reporting, 8) oversight and adherence to the IRB-approved protocol, 9) project finances.

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 research related experience - Required
• At least three (3) years of clinical 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 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.