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 support to the NCI's Center for Cancer Research (CCR), Office of Research Nursing (ORN).

KEY ROLES/RESPONSIBILITIES

• Alerts physicians of adverse events, abnormal outcomes or problematic trends, specifically in regards to protocol mandates
• Coordinates various activities to ensure proper and timely filing of serious adverse events, amendments, annual reports, and other regulatory documents
• 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
• Appropriately screens and collects blood samples from patients and donors
• Assists in managing patient files, copying and organizing research data
• 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
• Consults with other health care professionals to meet medical, psychological and/or social patient needs
• Coordinates patient schedules and provide information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
• Develops patient rapport and assist in explaining the protocol and tests/procedures to the patients
• 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 PIs, patients, and other staff members
• Recruits and enrolls patients
• 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
• Coordinates and reviews daily operations and logistics
• Ensures the communication of study changes to all care givers
• Interacts with auditing and monitoring agencies to facilitate the exchange of data
• Interfaces with the Protocol Support Office
• Manages and coordinates 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
• 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
• Works with the participating Branches within CCR to maintain protocol compliance and adherence
• This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland

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) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
• In addition to the education requirement, a minimum of five (5) years of progressively responsible experience
• 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
• 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

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• 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

JOB HAZARDS

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

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

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