Job Description

Senior Scientific and Healthcare Recruiter supporting the NIH, ARPA?H, VA, and other federal agencies as part of Kelly Government Solutions

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.

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