Clinical Research Nurse III - Developmental Therapeutic Clinic

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.

KEY ROLES/RESPONSIBILITIES

The Clinical Research Directorate (CRD) provides clinical research nursing support to NCI's Division of Cancer Treatment and Diagnosis, specifically to the Developmental Therapeutic Clinic.

• Serves as liaison between clinical and laboratory personnel and the NCI Developmental Therapeutics Principal Investigators
• Participates in clinical trials protocol development
• Develops procedure manuals for clinical trials protocols
• Assists in the creation of case report forms
• Advises on and participates in the management and evaluation of multiple clinical protocols
• Oversees ongoing protocol operations to ensure study compliance and troubleshoots possible protocol violations
• Interfaces with the Protocol Support Office
• Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
• Interacts with auditing and monitoring agencies to facilitate the exchange of data
• Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
• Monitors and oversees activities pertaining to clinical protocols such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials
• Ensures quality and human subjects protection
• Assists with writing protocols and protocol amendments to ensure regulatory requirements
• Assists the Principal Investigator in interpreting research data for dissemination to the protocol team
• May conduct updates for clinical staff on patient care, protocol process and progress, human subject's protection, ICH Good Clinical Practices, and quality assurance education
• May visit off-site collaborative centers
• Work is performed independently under the general guidance and direction of the supervisor
• This position is located 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).
• Foreign degrees must be evaluated for U.S. equivalency
• A minimum of one (1) year nursing and/or related clinical research experience
• Oncology and regulatory 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
• Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

• Experience in a clinical trials outpatient setting and/or experience in data management and collection
• Good communication skills