Position Objective: Provide services as a Research Nurse (Clinical Studies/Protocols) support of the overall functions of the Virology Branch (VB), Division of Microbiology and Infectious Diseases (DMID) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Work as a clinical project manager within the Virology Branch (VB) of the Division of Microbiology and Infectious Diseases (DMID) focusing on clinical protocol oversight and management of extramural clinical research.
• Serve as Project Manager, managing complex teams to meet milestones and timelines of multiple ongoing clinical studies, which includes organizing regular team teleconferences, maintaining spreadsheets, Gantt charts, and meeting agendas and minutes.
• Apply clinical protocol expertise/skills in developing study concepts, developing clinical protocols and study related documents, reviewing safety of studies, and overseeing investigator conduct and evaluating clinical site conduct.
• Develop clinical protocols and study related documents; assist with clinical protocol review and clinical outcomes evaluation.
• Upon assignment by the Branch, review protocols and all supporting documents for VB clinical research studies and trials.
• Utilize required electronic systems and software in support of clinical research activities.
• Advise study groups in the development of protocols in accordance with International Conference on Harmonization Good Clinical Practice Guidelines.
• Serve as a key member of study team overseeing clinical research activities involving vaccine, therapeutics and diagnostics for virologic diseases
• Evaluate the quality and appropriateness of clinical protocols proposed for implementation by the Branch.
• Serve as a point of contact for clinical protocol safety review teams, IRBs and their processes, and provide expertise on policies and guidelines that impact subjects enrolled in DMID sponsored studies as assigned by the Branch. Provide expertise on policies and guidelines that impact subjects enrolled in DMID sponsored studies.
• Serve as the liaison with academic, government, and industry partners on behalf of the Branch on clinical trial issues.
• Complete all DMID required training for the conduct and oversight of clinical research.

Basic Qualifications:

• RN or BSN is required.
• Minimum of five (5) years of related experience is required.

Minimum Qualifications:

• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.