Clinical Research Nurse II - Apheresis (NIH/NIAID)

About the Organization

The Frederick National Laboratory, operated by Leidos Biomedical Research, Inc., addresses urgent and intractable problems in biomedical sciences, including cancer, AIDS, drug development, nanotechnology in medicine, and emerging infectious diseases. The Clinical Research Directorate (CRD) within Leidos Biomedical Research provides clinical supervision and operational support for clinical research, including trials management, regulation, pharmacovigilance, and protocol development. CRD supports clinical trials at the NIH Clinical Center and other initiatives for the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), and other NIH institutes. CRD’s mission is to provide high-quality clinical research support in compliance with regulations, ensuring data integrity and protecting human subjects.

About the Role

This position supports NIAID protocols and research in collaboration with the Department of Transfusion Medicine (DTM). The role involves providing clinical support for an assigned caseload of research protocols, working in a multidisciplinary environment to assist with clinical implementation.

Responsibilities

• Coordinates research specimen procurement and processing.
• Obtains consent for send-in samples and assists with specimen procurement procedures.
• Logs received samples in appropriate databases and processes outside material through NIH departments.
• Assists in the coordination and implementation of clinical trials.
• Manages and analyzes protocol data, organizes study files, and maintains databases.
• Assists with monitoring and compliance of regulatory requirements.
• Creates and prepares protocol training materials.
• Performs donor phlebotomy, donor and therapeutic apheresis according to DTM standard operating procedures.
• Reviews patient/donor information and product data, identifies abnormal values, and initiates follow-up.
• Assesses donor/patient condition during apheresis procedures and whole blood donation; recognizes and treats reactions according to standard operating procedures.

Requirements

• Bachelor’s degree from an accredited college/university (or four years of relevant experience in lieu of a degree). Foreign degrees must be evaluated for U.S. equivalency.
• Minimum of two years of progressively responsible nursing/clinical experience.
• Current unencumbered professional license as a Registered Nurse (RN) from any U.S. state.
• Ability to wear personal protective equipment and CPR certification (or certifiability).
• Highly effective organizational, planning, problem-solving, and interpersonal skills.
• Working knowledge of biological principles, scientific methods, and ICH/GCP guidelines.
• Understanding of clinical research concepts, ethics, processes, and protocol implementation.
• Ability to obtain and maintain a security clearance.

Preferred Qualifications

• Prior experience in clinical trials and/or data management and collection.
• Experience or willingness to train in safe sample procurement, handling, and processing.
• Leadership experience in management, mentoring, or training roles.
• Experience in blood donor collections and/or apheresis procedures.

Job Hazards

This position is subject to atmospheric conditions requiring the use of a respirator, necessitating a medical clearance.

Schedule

Ability to work on-site during regular clinic hours, Monday through Friday, excluding Federal holidays. Ad hoc telework may be available as determined by clinical and protocol needs.

Pay

Competitive compensation within the range of $76,800.00 to $110,103.00 USD. The posted range is a general guideline and not a guarantee of compensation. Factors such as job responsibilities, education, experience, knowledge, skills, internal equity, and market data will be considered in extending an offer.

Benefits

Employment benefits include Health and Wellness programs, Income Protection, Paid Leave, and Retirement. More details are available on the organization’s benefits page.