Clinical Research Coordinator I - Profound Autism Research Study

SHIFT

• Day (United States of America) 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 A Clinical Research Coordinator position is open as part of a new large-scale longitudinal project spanning multiple departments (Developmental Behavioral Pediatrics, Neurology, Genetics, Center for Autism Research) at the Children’s Hospital of Philadelphia. This project is focused on advancing scientific discovery and creating more therapeutic opportunities for profoundly autistic individuals ranging from birth to 18 years of age. The CRC will be actively involved in recruiting families from CHOP specialty care and primary care settings, working with families and study clinicians to conduct study visits, and managing study data. Additional responsibilities include screening potential research participants and clinical patients for enrollment; scheduling and completing participant visits and collecting biospecimen samples (visits may occur on CHOP main campus, at external satellite sites or in the community); consenting participants and research families for enrollment; performing routine email and phone follow-up with consented families who have outstanding study-related tasks. Successful applicants will be highly self-motivated and fast learners who enjoy working in bustling research and clinical environments. 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. EEO / VEVRAA Federal Contractor |