Research/Regulatory Nurse Practitioner - Gene Therapy

Research/Regulatory Nurse Practitioner - Gene Therapy Requisition ID 2024-51682 Category Advanced Practice Provider Overview 1.0 FTE, 40 hours per week Competitive benefits package & pay based on experience level The Nurse Practitioner will function in accordance with the philosophy, policies, procedures and standards of NCH and functions within the APRN practice guidelines agreed upon by the medical and patient care services departments; as directed by the Principal Investigator (PI), this position performs all research patient management activities, specifically related to regulatory work, in conjunction with the Clinical Research Coordinators (CRCs) and co-Investigators (co-Is) on gene therapy trials. The Nurse Practitioner, in collaboration with the CRCs and Drug and Device Development Services (DDDS) staff, assists in the writing of FDA Annual Reports, OBA reporting, preparation of DSMB reports, and Clinical Study Reports. Works directly with CRCs, PI, and co-Is, on IRB submissions. Why Nationwide Children's Hospital? The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere. Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere. Nationwide Children's Hospital. A Place to Be Proud. Responsibilities 1. Patient Management: functions within the APN practice guidelines. Works directly with PI, Co-I, CRCs, and study staff in research patient visits and follow-up. Performs a complete standard physical examination, and distinguishes between normal and abnormal findings. 2. Reviews laboratory and imaging reports to assess findings in context of study protocols. 3. Conducts preliminary review of complex research protocols that propose the use of human subjects. Reviews the protocol submissions for completeness, identifies problems, performs quality control, and checks for compliance with current federal regulations. 4. Serves as the primary resource for investigators regarding the organizational IRB review requirements for research protocols. 5. Reviews all adverse events prior to submission to regulatory oversight committees 6. Provides training to investigators and study staff regarding the submission of new protocols, adverse events, and amendments to existing protocols following organization policies. 7. Tracks pending applications and advises investigators on the status of their submission. Identifies and tracks approved research protocols, including implementing office established procedures to assist investigators in complying with conditions imposed by the regulatory committees. 8. Oversees clinical trial record maintenance and ret