Clinical Research Nurse III - Genitourinary Malignancies Branch

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 to the National Cancer Institute's (NCI's), Center for Cancer Research (CRC), Genitourinary Malignancies Branch (GMB).

KEY ROLES/RESPONSIBILITIES

• Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
• Drafts source documents to be used in new studies
• Aids with all aspects of the protocol lifecycle including initial IND submission, IRB submission, continuing review applications, protocols, protocol amendments, annual reports, and protocol inactivation with IRB and FDA.
• Creates and maintains an IRB database of approved amendment descriptions
• Assists the Principal Investigator in data collection (including patient specimens) and data analysis; the writing of interim reports, annual protocol reports, and scientific publications; the interpretation of research data for the protocol team; and with 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
• Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
• Assists in the management of patient files, copying and organizing research data
• Confirms the collection of appropriate patient samples per protocol schema
• Coordinates patient schedules and provide information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
• Discusses toxicities experienced and drugs/dosages received by patient while at home
• Documents patient care via established guidelines
• Maintains communication with the patient's home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
• Recognizes and supports the needs of data integrity and retrieval, and interpret needs appropriately for Principal Investigators, patients and other staff members
• Recruits and enrolls patients
• Assists/trains local study staff in explaining the protocol and tests/procedures to the study participants
• Ensures scientific quality and human subject's protection
• 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
• Distributes test kits, coordinates outside specimens for testing and diagnostic purposes (including referring MDs, NIH labs and repositories) and log received samples in appropriate database
• Interacts with auditing and monitoring agencies to facilitate the exchange of data
• Manages and coordinate intramural and extramural sites participating in clinical protocols for which the Principal Investigator is the coordinating center
• Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
• Manages the implementation, tracking, data abstraction, collection, data reporting and coordination of a variety of Phase III clinical trials
• Obtains informed consent
• Orders labs, x-rays and other diagnostic procedures prescribed by the protocol and/or clinically indicated
• Oversees ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
• Participates in the management and evaluation of multiple international clinical protocols
• Works directly with investigators and medical writers on the production and revision of clinical research protocols and facilitate the activities of writing and regulatory review
• Works with site staff to put systems in place to ensure timely resolution of queries
• This position is location at the National Institutes of Health (NIH) in Bethesda, Maryland

BASIC QUALIFICATIONS

• 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)
• A minimum of one (1) year nursing and/or related clinical research experience
• Foreign degrees must be evaluated for U.S. equivalency
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Oncology experience
• Experience in a clinical trials outpatient setting and/or experience in data management and collection
• Experience in pediatric oncology, transplant and/or neuro-oncology

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)