As one of the nation’s leading pediatric health care systems, Nemours is committed to providing all children with their best chance to grow up healthy. We offer integrated, family-centered care to more than 300,000 children each year in our pediatric hospitals, specialty clinics and primary care practices in Delaware, Florida, Maryland, New Jersey and Pennsylvania. Nemours strives to ensure a healthier tomorrow for all children – even those who may never enter our doors – through our world-changing research, education and advocacy efforts. At Nemours, our Associates help us deliver on the promise we make to every family we have the privilege of serving: to treat their child as if they were our own.
The Regulatory Coordinator is responsible for overseeing the day-to-day regulatory management of all types of clinical research protocols. The position will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies including, the Institutional Biosafety Committee, the institutional Radiation Safety Committee, and the clinical trial sponsor, funding foundation, or governmental agency.
This 32 hour per week position will support the Nemours NCI Community Oncology Research Program (NCORP) component sites at Broward Health Medical Center, Ft. Lauderdale, FL as well as Sacred Heart Hospital, Pensacola, FL.
The associate must reside in close proximity to one of the institutions listed above. Up to 25% travel between sites will be required.
Bachelor's degree required (Clinical Health Science / Healthcare Administration preferred)
3-5 years related experience required
Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
Provide regulatory start-up support for research teams for all types of clinical trials.
Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
Oversee timely regulatory submissions to meet project timelines.
Create and maintain position related Standard Operating Procedures (SOPs) and ensures procedural compliance.
Identify program improvement opportunities and lead improvement efforts within team, including technology solutions; identify opportunities for expanding solutions to study teams.
Coordinate with appropriate department to address regulatory-related quality and compliance matters.
Assist with the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
Work with Quality Assurance to perform internal audits and quality assurance reviews on regulatory files, as needed
Write and edit clinical research protocol consent forms in accordance with federal regulations and guidelines and good clinical practice (GCP) guidelines.
Liaise with appropriate personnel, departments and outside entities on clinical trial regulatory operations.
Our dedication to professionals who are dedicated to children frequently earns Nemours a spot on the list of top workplaces in the communities we serve. Our Associates enjoy comprehensive benefits, including our unique “Bridge to a Healthy Future” pediatric health plan, an integrated wellness program, opportunities for professional growth, and much more. As an equal opportunity employer, Nemours focuses on the best-qualified applicants for our openings.
Nemours is committed to improving the health of children. As a non-profit children’s health organization, we consider the health of every child to be a sacred trust. Through family-centered care in our children’s hospitals and clinics in Delaware, New Jersey, Pennsylvania and Florida, as well as world-changing research, education and advocacy, Nemours fulfills the promise of a healthier tomorrow for all children — even those who may never enter our doors. Nemours began more than 70 years ago with the vision of Alfred I. duPont to improve the lives of children and to do whatever it takes to prevent and treat even the most disabling childhood conditions. Today, through our children’s hospitals and health system, we directly care for 250,000 children annually in Delaware Valley and Florida, including families who travel from across the country and world to see our specialists — treating every child as we would our own. We also reach beyond the walls of our hospitals and clinics to be a voice for children on a national and international level, and to lead the way in prevention, intervention, education, and research. Nemours is growing to better serve the children and families in our ca...re. We have 1.1 million square feet of space currently devoted to providing children’s healthcare or under construction, all designed with significant input and advice from our patients and families.