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 Manager of the Quality Assurance and Research Education Program will be responsible for executing and managing a comprehensive program to include quality assurance activities and clinical research staff education and training across the Nemours enterprise. The position will provide continuous monitoring and interpretation of relevant regulatory requirements, identification of regulatory and compliance risks in clinical research, ongoing clinical research coordinator education, and working with leadership to identify actions necessary to reduce or eliminate identified risks. The position will lead planning, development and implementation of clinical research training programs and continuous education programs.
Directs and oversees all quality assurance staff and functions in areas including FDA, IND, and ICH regulations and guidelines, and clinical research associate training
Serves as lead contact for inspections by regulatory agencies and sponsor audits
Develops, reviews and strengthens research policies, SOPs, and CAPAs
Develops plans and leads readiness for inspections and audits
Ensures completion of all corrective actions associated with the quality system and ensures that the CAPA process is compliant with regulatory requirements
Oversees and performs monitoring processes, including managing monitoring resources,tracking status of monitoring findings to closure, and retention of monitoring reports
Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries
Develops departmental curriculum for training programs for clinical research associates Responsible for both proactive and corrective education including onboarding education of new team members as well as ongoing education of teams based on gaps identified through internal audits, sponsor monitoring visits, changes in regulations, departmental/corporate policies and other factors as determined by department leadership
Participates and reports institutional risks to the Research Compliance Sub-Committee and manages policies and SOP’s through the Research Policy Committee
Comprehensive knowledge of FDA and ICH regulations and guidelines Minimum five years in a quality management role In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems Demonstrated experience identifying areas for improvement and implementing solutions; ensuring compliance with standards, regulations and company procedures; and administering successful programs within appropriate timelines
Experience conducting training with excellent interpersonal skills with proven written, presentation and verbal competencies
Ability to interact positively with all levels of staff and external contacts
Experience adopting a flexible, proactive, and service-oriented approach
Bachelor’s degree required; master’s degree and 5 years’ experience in a FDA regulated regulatory or compliance role including 5 years of management experience is preferred ;
Certified Clinical Research Coordinator (CCRC)
Certification in regulatory affairs, quality assurance or clinical research; (RAPS) Regulatory Affairs Professionals Society preferred
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.
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