Clinical Research Nurse II - NIH / NIAID

About the role

The Clinical Research Directorate (CRD) at Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, provides clinical supervision of programs at the clinical end of the research spectrum. CRD supports clinical trials at the NIH Clinical Center and other research services for NCI, NIAID, and other NIH institutes.

Responsibilities

• Recruits patients for clinical protocols
• Screens referrals
• Communicates with patients and referring providers about the protocol and enrollment process
• Documents screening activities in appropriate databases
• Determines eligibility of volunteers for participation in clinical trials
• Obtains informed consent
• Provides patient care to protocol patients
• Triages patient concerns and medical conditions
• Understands the conduct of study protocol
• Handles research samples, collects and delivers them
• Schedules required labs, diagnostic tests, consults
• Works with the travel team to arrange patient travel and lodging
• Communicates the schedule to patients
• Obtains consents for the release of medical records
• Facilitates the procurement of outside medical records and materials
• Organizes, files, and reviews outside medical records
• Coordinates research specimen procurement and processing
• Obtains consent for sending in samples
• Processes outside material through the appropriate NIH departments
• Aids in the coordination, handling, and shipment of study samples
• Aids in the coordination and implementation of clinical trials
• Manages and analyzes protocol data
• Organizes study files
• Maintains databases
• Aids in the monitoring of and compliance with regulatory requirements
• Aids in the creation and preparation of protocol training materials
• Collaborates with clinical staff to assist in the clinical implementation of the protocol

Requirements

• Possession of Bachelor’s degree from an accredited college/university or four (4) years relevant experience in lieu of degree
• Foreign degrees must be evaluated for U.S. equivalency
• Minimum of two (2) years of progressively responsible experience
• Current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
• Experience in managing complex study schedules
• Ability to work with sponsor provided electronic data systems and to enter required information
• Ability to wear personal protective equipment
• CPR certification or certifiable
• Highly effective organizational and planning, problem-solving, and interpersonal skills
• Working knowledge of biological principles and scientific methods
• Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation

Qualifications

• Experience in the fields of infectious disease, immunology, autoimmunity, and chronic illness disease processes
• Experience in clinical trials and/or experience in data management and collection
• Highly effective computer and communication skills

Skills

• Understanding of biological principles and scientific methods
• Knowledge of ICH/GCP guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation

Benefits

• Competitive compensation
• Health and wellness programs
• Income protection
• Paid leave
• Retirement

Pay and Benefits

The posted pay range for this job is $76,800.00 - $110,103.00 USD. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data. The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions.