Clinical Research Nurse III - NIH/ NCI
Job ID: req3742
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., the Clinical Research Directorate (CRD), various clinical support teams provide high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CRD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’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 support for the National Cancer Institute (NCI), Center for Cancer Research (CCR), Office of Research Nursing (ORN).
- Alerts physicians of adverse events, abnormal outcomes, or problematic trends, adhering to protocol mandates and ensures proper and timely filing of these occurrences.
- Creates and maintains IRB database of approved amendment descriptions
- Assists the Principal Investigator (PI) in data collection (including patient specimens) and data analysis; writing interim reports, annual protocol reports, and scientific publications; interpretation of research data for the protocol team; and performing site visits
- Completes flow sheets and case report forms according to the provisions of approved investigational protocols
- Coordinates Clinical Trial Agreement requirements with applicable Clinical Research Oversight Managers (e.g., safety reporting requirements) and data management if data is to be provided to third party at end of trial
- Works with the Clinical Trials Management Research Oversight Manager to ensure consistency of case report forms with the management plan and coordinate site initiation and other monitoring site visits with all necessary parties
- Appropriately screens and collects blood samples from patients and donors per protocol schema
- Collaborates with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data
- Conducts updates for clinical staff on patient care, protocol process and progress, human subject’s protection, ICH GCPs, and quality assurance education
- Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
- Defines, establishes, and manages inclusion criteria such as patient population, diagnostic criteria, and patient condition
- Develops patient rapport and assists in explaining the protocol and tests/procedures to the patients
- Discusses toxicities experienced and drugs/dosages received by patient while at home
- Maintains communication with the patient’s home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
- Recruits and enrolls patients
- Assists in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
- Participates in quality improvement and quality assurance initiatives involving database and data system development efforts as well as training programs for research nurses
- Collects and interprets data as specified by the investigators in support of the clinical trial including drug administration, toxicity, laboratory parameters and response interpretation
- Collects and maintains current regulatory documentation from numerous ongoing clinical trials
- Interacts with auditing and monitoring agencies to facilitate the exchange of data
- Interfaces with the Protocol Support Office
- Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
- Manages implementation, tracking, data abstraction, collection, data reporting and coordination of a variety of Phase III clinical trials
- Obtains informed consent
- Serves as liaison between investigators, the IRB, and the study DSMB
- Works with site staff to put systems in place to ensure timely resolution of queries
- Works with the participating Branches within CCR to maintain protocol compliance and adherence
- This position is location at the National Institutes of Health (NIH) in Bethesda, Maryland
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a bachelor’s degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Additional qualifying experience may be substituted for the required education.
- Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed
- Current State license as a registered nurse (RN)
- Foreign degrees must be evaluated for U.S. equivalency
- In addition to the educational requirements, a minimum of five (5) years nursing and/or related clinical research experience
- Knowledge of clinical research data collection and clinical data report preparation
- Demonstrated experience in the coordination, implementation, and execution of clinical trials
- Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
- Ability to obtain and maintain a security clearance
Candidates with these desired skills will be given preferential consideration:
- Ability to apply knowledge to the clinical care of cancer patients
- Ability to provide emotional support in helping patients cope with stress associated with cancer
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
- 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.