Clinical Research Coordinator I - Critical Care Medicine

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

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. 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.

Requirements

High School Diploma / GED - Required
At least two (2) years of clinical or research related experience - Required
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

Nice To Haves

Bachelor's Degree - Preferred
At least three (3) years of clinical or research related experience - Preferred

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
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