Apheresis Clinical Research Nurse I/II
Job ID: req3771
Employee Type: exempt full-time
Division: Clinical Research Program
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum. The quality assurance programs provide the required autonomy and transparency of Good Manufacturing Practice quality assurance operations. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations. These support services include dedicated clinical research professionals who provide patient care to clinical trial participants at the National Institutes of Health (NIH) Clinical Center, and other research services that support the domestic and international clinical research initiatives of the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and several other institutes within NIH. CRD’s support services are strategically aligned with its mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, protecting human subjects, and helping to advance scientific clinical research. CRD facilitates the conduct of NIH-sponsored clinical trials that investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, parasitic infections, heart, lung and blood disorders, and rare and neglected diseases. CRD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CRD’s mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Research Directorate (CRD) provides clinical research nursing coordination and support to the Intramural Clinical Management and Operations Branch (ICMOB), Division of Intramural Research (DIR), National Institute of Allergy & Infectious Diseases (NIAID). This Position is in support of NIAID protocols and research in collaboration with the Department of Transfusion Medicine (DTM).
*This position can be hired as a Clinical Research Nurse I or II.
Provides clinical support to an assigned caseload of research protocols (including, but not limited to):
• Coordinates research specimen procurement and processing
o Obtains consent for send in samples
o Assists with specimen procurement procedures
o Logs received samples in appropriate databases
o Processes outside material through the appropriate NIH departments
• Assists in the coordination and implementation of clinical trials
o Manages and analyzes protocol data
o Organizes study files
o Maintains databases
o Assists with the monitoring of and compliance with regulatory requirements
o Assists with the creation and preparation of protocol training materials
o Works collaboratively in a multidisciplinary environment to assist clinical staff with clinical implementation of the protocol
• Performs donor phlebotomy, donor and therapeutic apheresis according to DTM standard operating procedures
• Enhances professional growth and development through participation in educational programs, reviewing current literature, attending in-service meetings, and workshops
• Reviews all 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
• Ability to work on-site during regular clinic hours Monday - Friday, excluding Federal holidays. Ad hoc telework available as determined by clinical and protocol needs
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
• Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field. Foreign degrees must be evaluated for U.S. equivalency. Additional qualifying experience may be substituted for the required education
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
• In addition to educational requirements:
o Clinical Research Nurse I – No additional nursing/clinical experience
o Clinical Research Nurse II – A minimum of two (2) years of nursing/clinical experience
• Ability to wear personal protective equipment
• Must be CPR certified 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
• Must be able to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
• Prior experience in clinical trials and/or experience in data management and collection
• Experience or willingness to train in safe sample procurement, handling and processing practices
• Leadership experience in management, mentoring or training roles
• Experience in blood donor collections and/or apheresis procedures
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.