Clinical Research Coordinator I - Lynch Lab

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

Under moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols. The Lynch Lab employs cutting-edge biomedical optical tools to better understand risk for neurologic injury in children with cardiac diseases. Our innovative approach revolves around noninvasive techniques for measuring cerebral oxygen delivery and utilization, ushering in a new era of neuromonitoring and improved neurologic outcomes. Our research covers a wide range of areas, from studying the vulnerable period after birth when infants with critical congenital heart disease are awaiting their life-saving procedures to improving neurologic outcomes during neonatal cardiac surgeries. We're also investigating the neurologic impact of procedures like device closure of patent ductus arteriosus in premature babies, monitoring intracranial pressure in patients with Glenn physiology, and measuring tissue water content in patients with lymphatic abnormalities. Our interdisciplinary approach sets our lab apart. Dr. Lynch's unique background in both physics and pediatric cardiac anesthesia brings together the worlds of science and medicine. Through close collaboration with other labs in the CHOP Biomedical Optics Group and researchers at the University of Pennsylvania, we combine cutting-edge technology with clinical experience to find practical solutions for better neuromonitoring and improved neurologic outcomes in children with heart conditions. Join us in our quest to make a real impact in pediatric cardiac care, one optical innovation at a time.

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