Nemours Children's Health·Wilmington, Delaware
The coordinator implements and manages clinical research studies within the Orthopedics Department, handling everything from regulatory documentation to participant recruitment. They are responsible for data integrity, interfacing with sponsors, and mentoring new research coordinators.
Nemours is seeking a Clinical Research Coordinator to join our Nemours Children's Health team in Wilmington, DE.
The Clinical Research Coordinator II coordinates, implements and completes clinical research studies and/or clinical trials in the Orthopedics Department at Nemours Children's Hospital Delaware by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned;
2. Understands and can conduct clinical research studies that require but not limited to, DSMB, Emergent Access, Conduct Investigator Initiated studies, Multi-site clinical trials, Research Team training manuals.
3. Achieves clinical research coordinator certification from ACRP or SOCRA.
4. Develops source documents, parental permission and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
5. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
6. Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains study databases
7. Mentors new clinical research coordinators. Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
8. Assists in identifying, reporting and following-up on Serious Adverse Events.
9. Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
10. Coordinates monitoring activities with Sponsor’s representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children’s hospitals — Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships.
Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive.
Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.
Learn more at Nemours.org [https://www.nemours.org].
Market context
Clinical research coordinator roles in orthopedics are typically driven by ongoing studies, patient enrollment needs, and site-level research activity in Delaware health systems. This category is competitive because employers often want a science degree, several years of research experience, and ACRP or SOCRA certification or eligibility. Review the AI-summarized requirements and benefits here to save time, then confirm your certification status and highlight any orthopedic or coordination experience in your application.
Histotechnologist (Casual/PRN)
ED Tech (8P-8A)
RN - 3E, Intermediate Care Unit