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 Hem/Onc Lead Clinical Research Nurse coordinates, implements and completes Children’s Oncology Group (COG) studies or industry sponsored clinical trials by assisting in regulatory document preparation and collection, in-servicing research teams, screening/enrolling study participants, obtaining parental permission/assent, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, grading/reporting severe adverse events, maintaining study records, interfacing with study sponsors, participation in sponsor study monitoring visits.
Primary Responsibilities and Required Skills:
Good communication skills and a teamwork attitude.
Demonstrate autonomy as well as the ability to collaborate within a multidisciplinary health care team.
Detail oriented with good time management skills.
Ability to prioritize appropriately to meet deadlines.
Ability to maintain and organize multiple open clinical protocols; Ability to manage up to 20 active on study patients in various stages of the protocol
Acts as key point of contact for: Information from NCI Clinical Trials Support Unit (CTSU); Information to site from COG Data Center regarding data queries; Site Initiation Visits (SIV)/trainings, query resolution and close- outs; External ancillary services such as IROC, BPC and COG research labs; COG QA and audit.
Responsible for distribution of COG announcements including weekly newsletters as well as urgent action alerts such as action letters, closure notifications, family letters etc.
Contribute to the success of clinical trials through confirming study eligibility and study enrollment; regulatory compliance; timely data submission; adverse event grading and reporting and sample submissions.
Coordinate and participate in site monitoring visits for Industry sponsored trials. Responds to sponsors queries and completes case report forms in a timely manner. Prepares for and participates in COG audits every three years.
Performs clinical data gathering and monitoring of data integrity, including data completeness, accuracy and quality. Audits source documentation. Maintains study database (CREDIT).
Assists in the maintenance of study medication accountability records; assists pharmacy with Investigational New Drug (IND) accountability.
Study coordination and communication for internal ancillary services such as radiology, pathology, neuropsychology, surgery and radiotherapy with regard to protocol questions, clarification and processes
Assist Nemours Office of Sponsored Projects (OSP) with budget negotiations.
3-5 years related experience
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 a pediatric health system of hospitals and specialty clinics serving children and families throughout the Delaware Valley and Florida. Our dedicated professionals integrate medical care, research, health education, and prevention to help improve the lives of children every day.