Clinical Research Nurse

The Nemours Foundation; Wilmington (DE); On-site; USD 65,000 - 90,000; Full time

Job summary

Nemours is seeking a Clinical Research Nurse to join the PICU research program in Wilmington, DE.

You will support, expand, and lead clinical research, manage data, coordinate with sponsor audits, and mentor study staff.

The role requires nursing licensure in Delaware and clinical research experience, with comfort working with children and families.

Qualifications

• Experience in health care or clinical research.
• Familiarity with human subjects’ research regulations.
• Ability to work with families, children, and staff.
• Proficient data entry and management with common software.
• Career advancement opportunities supported by the company.

Responsibilities

• Follow SOPs and GCP; collect and prepare documents; attend investigator meetings.
• Conduct studies including Emergent Access, multi-site trials, and Investigator Initiated studies; follow training manuals.
• Assist in parental permission/assent; schedule visits; ensure protocol compliance.
• Gather and monitor data; maintain study databases; address sponsor queries.
• Train nursing staff and coordinate with departments to ensure protocol adherence.
• Identify and report Serious Adverse Events and unexpected problems.
• Maintain study drug accountability; coordinate with research pharmacist.
• Prepare specimens for shipment; ensure procedures are followed.
• Coordinate monitoring with sponsor; complete CRFs; prepare for audits.
• Participate in process improvement initiatives and outcomes.
• Prepare for audits and corrective action plans.

Skills

Clinical research experience

Data entry and data management

Ability to work with children

Regulatory knowledge (human subjects)

Team collaboration

Education

Associate degree in Nursing (ASN)

BSN preferred

Delaware Nursing License

CRC certification or eligible

Tools

Microsoft Word

Excel

Adobe Acrobat

Job description

Nemours is seeking a Clinical Research Nurse to join our team in Wilmington, DE.

The Division of Critical Care at Nemours Children’s Hospital Delaware is seeking a Clinical Research Nurse (CRN) to support, expand, and lead the clinical research program within the pediatric intensive care unit (PICU). Applicants should be motivated to work with families, children, and staff in a highly collaborative environment focused on outstanding clinical care, education, and research. The CRC/CRN will join a productive research team that is overseen by a Research Manager and the Director of Research for the PICU.

Candidates should have familiarity and experience with human subjects’ research regulations, though additional professional development in this area will also be provided. Prior experience working in health care or clinical research is required. Additional required skills include ability to work with children, experience with computer data entry and management, and familiarity with common computer programs, such as Microsoft Word and Excel and Adobe. CRCs and CRNs in Critical Care are also expected to pursue, and will be supported in their pursuit, of career advancement opportunities.

The PICU at Nemours embraces a multi-professional, multi-specialty collaborative care model that is patient- and family-centered. As one of the nation's premier pediatric health care systems, Nemours is committed to do whatever it takes to prevent and treat even the most disabling childhood conditions. It's a promise that extends beyond our nationally recognized clinical treatment to an entire integrated spectrum of research, advocacy, education, and prevention.

Essential Functions:

1. 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. 2.Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
3. 3.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.
4. 4.Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
5. 5.Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
6. 6.Assists in identifying, reporting and following up on Serious Adverse Events and/or Unanticipated problems
7. 7.Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
8. 8.Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
9. 9.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.
10. 10.Participates in continuous process improvement initiatives and implementation of outcomes
11. 11.Prepares for internal and external audits. Prepares corrective action plans as indicated.

Requirements:

ASN Required, BSN preferred. Associate degree in Nursing will require obtaining BSN within 3 years of hire date.

Active Delaware Nursing License

Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience

1 year of Clinical Research experience required

Basic Life Support Certification

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