Clinical Research Regulatory Specialist - Profound Autism Research Study and Orphan Disease Center

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 This position is responsible for assisting with the preparation, review, and submission of all protocols, amendments, informed consent documents, annual reviews, and safety reports to the IRB for a large-scale longitudinal research project spanning multiple departments, including Developmental Behavioral Pediatrics, Neurology, Genetics, and the Center for Autism Research at Children's Hospital of Philadelphia. The role also provides regulatory support to the Orphan Disease Center at the University of Pennsylvania, ensuring consistent regulatory practices across studies. This position leverages experience contributing to the development and submission of IND applications and/or IRB protocols, ensuring compliance with regulatory requirements. This role assumes a central, key supportive role for all studies. This position will also serve as a central resource for all regulatory matters and may assist in the training of new employees. This role is responsible to ensure standardization of all study regulatory binders. This includes assisting with the creation of regulatory binders for new studies and ensuring that study coordinators maintain updated regulatory binders for all active studies. This position will assist with the off-site storage of all files once a study has completed. This ideal candidate must be knowledgeable on, have full understanding of, and promote good clinical practices (GCP) and will be held accountable for adherence to all policies and procedures surrounding these processes and for maintaining up to date knowledge on these policies from IRB, FDA, ICH, GCP, or other sources.