Job ID: req2923
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: Telework: US
Location: 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 support for the National Cancer Institute (NCI), Center for Cancer Research (CCR), Genitourinary Malignancies Branch (GMB).
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
- Drafts source documents to be used in new studies
- Provides assistance for 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
- Create and maintain 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
- Follows up on monitoring reports to ensure that identified problems are adequately addressed and resolved
- 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
- 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 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
- 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
- Assists in the management of patient data for the Protocol Chairman of a variety of clinical trials
- 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
- Assesses, plans, and follows up with disease-noted attributes
- Assists in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
- Assits/trains local study staff in explaining the protocol and test/procedures to the study participants
- Participates in quality improvement and quality assurance initiatives involving database and data system development efforts as well as training programs for research nurses
- 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
- Coordinates and reviews daily operations and logistics
- Coordinates the writing and regulatory review process and assists investigators and medical writers on the production/revision of clinical research protocols and ensures IRD and FDA stipulations are appropriately addressed in a timely manner
- 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
- Manages quality assurance and quality improvement initiatives
- Manages, drafts, and reviews program correspondence and flow of information, direction, planning, etc. for the projects as they migrate between the various groups
- Manages implementation, tracking, data abstraction, collection, data reporting and coordination of a variety of Phase III clinical trials
- Obtains informed consent
- Oversees ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations
- Participates in the management and evaluation of multiple international clinical protocols
- Provides support top the research team for research in an emerging clinical area to include clinical trial support for combination therapies and translational research
- 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
**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL**
BASIC QUALIFICATIONS
- 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
PREFERRED QUALIFICATIONS
- HIV and AIDS experience
- Experience in a clinical trials outpatient setting and/or experience in data management and collection
JOB HAZARDS
- This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations
- This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)
#readytowork