Apheresis Clinical Research Nurse I

2 weeks ago

Bethesda, Maryland, United States Frederick National Laboratory for Cancer Research Full time

Apheresis Clinical Research Nurse I / II

Job ID: req3993
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
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.

PROGRAM DESCRIPTION

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).

KEY ROLES/RESPONSIBILITIES

Provides clinical support to an assigned caseload of research protocols (including, but not limited to):

Coordinates research specimen procurement and processing
Obtains consent for send in samples
Assists with specimen procurement procedures
Logs received samples in appropriate databases
Processes outside material through the appropriate NIH departments

Assists in the coordination and implementation of clinical trials
Manages and analyzes protocol data
Organizes study files
Maintains databases

Assists with the monitoring of and compliance with regulatory requirements
Assists with the creation and preparation of protocol training materials
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

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Possession of Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency
Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state

In addition to the education requirements:
Clinical Research Nurse I – No work experience required with a Bachelors degree
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
Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

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

JOB HAZARDS
This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance
This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
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.

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