Research Nurse (RN) - NIH New

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with leading medical research centers, biotechnology and pharmaceutical development companies in the world. We are seeking individuals qualified to work as a Research Nurse (RN) to support the mission of the National Institutes of Health (NIH).

This is a long-term contract position which offers:

-Competitive compensation and comprehensive benefit package

-Optional health, vision, and dental plans

-Paid time off, 11 paid federal holidays, and 401K plan

Schedule:

Work will be performed up to 40 hours per week during normal business hours, Monday-Friday, excluding Federal holidays. However, work can run past business hours, and flexibility will be needed.

Duties:

• Provide support of the overall functions of the Laboratory of Immunoregulation (LIR), Division of Intramural Research (DIR) identification.

• Screening and enrollment of patients in IRB approved clinical trial

protocols.

• Manage clinical protocols by performing study start-up, in-services, overseeing compliance to

protocol; developing and adhering to relevant SOPs; managing the quality control, completion

and submission of study related documentation; preparing, submitting and maintaining IRB,

FDA, and/or other regulatory documents and research correspondence.

• Monitor study enrollment goals and initiate strategies to promote enrollment and participant

compliance. Coordinate and perform responsibilities related to research participants including

determining subject eligibility, developing informed consents and screening materials, screening

and recruiting subjects, scheduling visits, scheduling informed consent with investigators and

overseeing study visits.

• Ensure efficient monitoring of all trials.

• Assist with site initiation activities, assist with the set-up and maintenance of studies.

• Maintain both new and ongoing IRB processes.

• Submit annual IRB continuing reviews, modifications and problem reports in a timely manner.

• Interface with both outpatient and inpatient units for scheduling, medication administration and

follow-up visits as outlined in the protocol.

• Coordinate evaluation and testing of referred individuals including obtaining relevant prior

medical records and blood / pathological specimens.

• Obtain medical records, radiological scans and pathology slides when applicable. Provide

summaries of records including medical history.

• Prepare reports for DSMB/SMC, review with Principal Investigators, attend DSMB/SMC requests and respond to additional requests as needed.

• Maintain excellent communication with pharmaceutical partners preparing summary reports of

enrollment, adverse events and other deliverables as specified in protocol/mutual agreements.

• Prepare reports summarizing clinical and research information gained for purposes of

communication with the Institutional Review Board and publication.

• Assist in communication with referring and local physicians and serves as an initial point of

contact for questions from patients.

• Interface with laboratories to ensure correct and timely specimen collection and track

results of testing.

• Track and obtain knowledge to observe and report adverse/serious adverse events, protocol

violations/deviations in a timely and accurate manner.

• Manage close-out of clinical protocol including audit preparation, trial closure, and

communication with regulatory agencies, assisting in the final study report and completing

financial obligations.

Specific Qualifications:

• Registered nursing license (RN) required – Maryland.

• Experience with performing study start up and management of IND clinical trials.

• Effective communication skills working in a team atmosphere.

• Willingness and ability to work flexible hours when experimental needs require it

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.

As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kelly’s Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what’s next.