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, Delaware. The role joins a productive research team overseen by a Research Manager and the Director of Research for the PICU. The position works with children, families, and staff in a collaborative environment focused on clinical care, education, and research. The PICU uses a multiprofessional, multispecialty, patient- and family-centered care model. The Clinical Research Nurse follows clinical research regulations and practices and supports studies from participant consent and scheduling through data management, medication accountability, specimen preparation, sponsor monitoring, and audits. Familiarity with human-subjects research regulations is expected, with additional professional development provided. The role also supports staff training, protocol compliance, and continuous process improvement. Candidates are supported in pursuing career advancement opportunities.
Requirements
- Associate degree in Nursing (ASN) required; an associate-degree nurse must obtain a BSN within three years of hire.
- Active Delaware nursing license.
- One year of clinical research experience required.
- Clinical Research Coordinator certification, or eligibility to sit for the certification exam after two years of clinical research coordination 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 with human-subjects research regulations.
Nice To Haves
- Bachelor of Science in Nursing (BSN) preferred.
Responsibilities
- Follow Standard Operating Procedures and Good Clinical Practices; collect and prepare documents required by sponsoring agencies and attend assigned Investigator Meetings.
- Conduct clinical research studies, including emergent access or compassionate-use studies, multisite clinical trials, investigator-initiated studies, and research team training manual activities.
- Participate in parental permission and assent processes; schedule study visits according to protocols and develop strategies to support participant compliance.
- Gather clinical data and monitor its integrity, completeness, accuracy, and quality; maintain multiple study databases, submit data proactively, and address queries promptly.
- Train nursing and ancillary study staff for study purposes 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 study medication accountability records and coordinate study drug administration and documentation with the research pharmacist.
- Prepare clinical specimens for shipment to central laboratories and ensure procedures and documentation requirements are followed.
- Coordinate sponsor monitoring activities, 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
