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 Director, Clinical ResearchServices will provide operational leadership for the Nemours clinical trials office. The successful candidate will be responsible for the oversight of clinical trial processes and the administration of clinical trials. The candidate will ensure adherence to SOP’s, Good Clinical Practice and FDA regulations. Incumbent will be expected to be able to ensure GCP compliance in all clinical trials. The Director, Clinical Research Services will partner with quality assurance and be involved in training of study coordinators; developing systems which track status of projects and effectively manage the scope, scheduling and resources for trails. They will also assist with financial management of the clinical trial program, including budget planning and resource allocation. The Director, Clinical Research Services is responsible in the oversight of clinical research throughout the Nemours enterprise. This position will directly supervise clinical research core in Central Florida and work with clinical trial managers in North Florida and the Delaware Valley.
Experience with research protocols and regulatory or governing bodies, including HIPAA and FDA regulations, IRB requirements, and Good Clinical Practices
Ability to Work collaboratively with cross functional internal groups/teams
Ability to create and manage internal and external budgets for research protocols
Experience with developing systems to manage/track productivity of clinical research functions
Experience with monthly reporting to research leadership regarding clinical research
Experience creating and documenting policies and Standard Operating Procedures (SOPs) for clinical operations
Experience leading the troubleshooting process to reach resolutions for any issues that arise during the course of a study
Oversee, lead, and manage cross-functional team resources and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to conduct clinical trials on time, on budget, in compliance, and of highest quality.
Work with research leadership to develop clinical research strategic plans and objectives
Help develop best practices, methods, techniques, and operational standards for clinical research coordination at Nemours
Collaborate with Quality Assurance to develop quality plans for the conduct of clinical trials at Nemours
Develop, update, and maintain SOP’s for clinical research across all sites
Ensure federal regulations are followed and serve as subject matter expert for the submission of IND’s, and IDE’s at Nemours
Track, report, and review study quality metrics and identifies activities warranted to meet trial goals and timelines
Supervise clinical research core managers and leads across the Nemours enterprise
Write, prepare, and/or contribute to clinical protocols and amendments, ICFs, CRFs, study manuals and other clinical documents
Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives.
Ensure clinical trial team and clinical trial sites are properly trained and in compliance protocols, drive site selection, and patient recruitment programs that deliver enrollment targets. Performs site monitoring with field team, as needed.
Responsible for ensuring the trial is “audit ready” at all times.
Performs oversight of trial to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
Provides regular updates to management team, vendors and contract staff concerning status and progress of the trial.
Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to management team, including current status of study milestones and forecast budgetary requirements based on scope of work.
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.