Clinical Research Nurse
About The Position
Nemours is seeking a Clinical Research Nurse to support, expand, and lead the clinical research program within the pediatric intensive care unit (PICU) at Nemours Children’s Hospital Delaware in Wilmington, DE. The nurse will join a productive research team overseen by a Research Manager and the Director of Research for the PICU. The role involves working collaboratively with families, children, and staff in an environment focused on clinical care, education, and research. Familiarity and experience with human subjects research regulations are expected, with additional professional development available. Career advancement opportunities are supported. The PICU follows a multi-professional, multi-specialty collaborative care model that is patient- and family-centered.
Requirements
- Associate of Science in Nursing (ASN) required; a Bachelor of Science in Nursing (BSN) is preferred.
- An associate degree in Nursing requires obtaining a BSN within three years of hire.
- Active Delaware nursing license.
- Clinical Research Coordinator certification, or eligibility to sit for the exam after two years of clinical research coordination experience.
- At least one year of clinical research experience.
- Basic Life Support certification.
- Prior experience working in health care or clinical research.
- Ability to work with children.
- Experience with computer data entry and management.
- Familiarity with common computer programs, including Microsoft Word, Excel, and Adobe.
- Familiarity and experience with human subjects research regulations.
Nice To Haves
- Bachelor of Science in Nursing (BSN).
Responsibilities
- Follow Standard Operating Procedures and Good Clinical Practices in conducting clinical research; collect and prepare documents required by sponsoring agencies and attend Investigator Meetings as assigned.
- Conduct clinical research studies, including emergent access/compassionate use, multisite clinical trials, investigator-initiated studies, and research team training manual activities.
- Participate in parental permission and assent processes; schedule study visits according to study protocols and develop strategies to support participant compliance with protocol requirements.
- Gather clinical data, measure and monitor data integrity, and maintain multiple study databases; submit data proactively and address queries promptly.
- Participate in training nursing and ancillary study staff and build relationships with departments to support protocol compliance.
- Assist with identifying, reporting, and following up on Serious Adverse Events and unanticipated problems.
- Assist with maintaining study medication accountability records and coordinate study drug administration and documentation with the research pharmacist.
- Prepare clinical specimens for shipment to central laboratories, follow manuals of procedures, and ensure applicable documentation accompanies samples.
- Coordinate monitoring activities with sponsor representatives; complete Case Report Forms, respond to sponsor queries, and prepare for sponsor, IRB, and FDA/DHHS audits.
- Participate in continuous process improvement initiatives and implement outcomes.
- Prepare for internal and external audits and prepare corrective action plans as indicated.
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What This Job Offers
Job Type
Full-time
Education Level
Associate degree
