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 Clinical Research Nurse - Cystic Fibrosis is responsible for coordinating all aspects of a clinical trial under the direction of the Principal Investigator. The responsibilities include, but are limited to, assessing protocol feasibility and staff availability, creating budgets, assisting with regulatory functions, capturing site staff training, recruiting participants, obtaining informed consents/assents, conducting efficient study visits based on protocol-directed procedures and timelines, providing verifiable data, interfacing with the sponsor, monitors and study vendors and ongoing monitoring for participant safety. The Clinical Research Nurse is also responsible for the management and accountability of study supplies, study equipment and study medications.
Bachelor's in Nursing required
At least 3-5 years experience required
Works under the direction of the Principal Investigator
Able to extract pertinent information from study protocols to determine feasibility of participation, to create fiscally responsible budgets and to capture data appropriately.
Able to travel to attend research related activities, such as Investigator Meetings, Educational Sessions
Able to coordinate and manage the conduct of multiple clinical trials under the direction of the Principal Investigator and in compliance with GCP standards to ensure appropriate documentation of site training and adherence with protocol directives/timelines, to capture clean verifiable data, to monitor participant safety parameters, and to practice within the guidance of the IRB. Recruits and consents study participants.
Works collaboratively with Clinical Departmental staff, the Regulatory Coordinator and the Office of Sponsored Projects.
Fosters professional relationships with external organizations, ie, Pharmaceutical Sponsors, Clinical Research Organizations, Wolfson Children’s Hospital Clinical Research Center, Wolfson Children’s Hospital Research Pharmacy, etc
. Possesses knowledge of diseases/disorders in children, ex: Cystic Fibrosis Establishes an effective working relationship with the participants and families.
Coordinate work effort to ensure Principal Investigator involvement
Procedures: Expertise with venipuncture skills - preferred;
Experience in performing spirometry, ecg and sweat chloride testing and blood / urine / sputum specimen processing - beneficial.
Administer medications and Investigational Products (oral, inhalation, intravenous, intramuscular, subcutaneous, topical)
Manage and maintain accountability of study medications, lab supplies and study equipment
Must be organized and detail oriented with study data capture: source documents, accountability records, medical/medication history records
Maintain comprehensive record keeping: site staff training, enrollment records, equipment calibration, etc.
Access/enter data in a variety of electronic data capture systems, web-based study medication systems and other study system portals.
Work collaboratively with study monitors, data management and sponsors to respond to queries and to ensure clean verifiable data and site documents are audit-ready.
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.