Clinical Research Nurse III

The Frederick National Laboratory is 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 Monitoring Research Program Directorate (CMRPD) provides strategic, operational, and program/project management support to domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and various other institutes within the National Institutes of Health (NIH). CMRPD’s services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist NIH researchers in providing the highest quality of clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. These clinical trials investigate the prevention, diagnosis, and therapeutic treatment of cancer, influenza, HIV, and other diseases and disorders. CMRPD is providing support to NCI’s Division of Cancer Treatment and Diagnosis (DCTD) Virtual Clinical Trials Office (VCTO) pilot. The pilot aims to determine if participant enrollment to NCI clinical trials, particularly for minority and underserved populations, can be improved by establishing a team of virtual research support staff to provide remote, centralized support to U.S. NCI research sites, including those sites participating in the NCI Community Oncology Research Program (NCORP). The remote support team will supplement and compliment the clinical site staff at NCI research sites to offset clinical-trial specific activities, including subject screening, enrollment, and data entry. A research nurse is required to implement and lead the VRS team in support of this program. The position is 100% remote. Candidates must reside in the U.S.

Collaboration and Leadership: Serves as the clinical expert for a team of clinical research professionals, providing education to team members on disease processes, treatment modalities, and best practices Coordinates with team leads to perform routine quality control checks, communicates findings, and provides staff education/training to improve team performance Provides coverage for team leads, including leading team and site meetings Works with pilot administrative leadership to coordinate, implement, and monitor pilot expansion Identifies and implements additional opportunities to further minimize the research burden on the clinical site research staff and study participants Works with clinical site staff to coordinate care and provides education on research needs/requirements and VCTO procedures Ability to adapt to evolving requirements and willingness to perform a variety of tasks that may be required to launch and implement the VCTO program Participant Identification, Screening, and Enrollment: Communicates with potential clinical trial participants and referring providers about the screening and enrollment process Facilitates the procurement of outside medical records and materials, and appropriately organize and file those materials Reviews participant materials to appropriately advise local teams on potential participant eligibility for protocols Documents screening and enrollment activities in appropriate databases (e.g., NCI Oncology Patient Enrollment Network, also known at OPEN) Participant Management: Assists with participant retention efforts Reviews medical records to identify con-meds and AEs/unanticipated problems/SAEs Provides medical coding to ensure standardization of terminology and grading Tracks AEs/SAEs through end of event Maintains accurate con-meds and problem lists Assists study sites with follow-up AE/SAE reporting requirements and close-out procedures Data Management: Completes the collection and entry of research participant data and study-related information sourced from the Electronic Health Record (e.g., Epic, Cerner, etc.) into electronic clinical data capturing systems (e.g., eCRFs, Medidata Rave, REDCap) and clinical trial management systems (e.g., OnCore, Florence e-Reg, Velos eResearch, Complion, etc.) timely and accurately to ensure data integrity Tracks and confirms source materials (i.e., images, path) and submit for protocol-defined processing Files and maintains records in accordance with protocol and site-specific guidance Evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of clinical trial participant data Collaborates with local site staff and remote VCTO team members to resolve queries to meet protocol requirements in an efficient and effective manner Alerts site study teams to adverse events, abnormal outcomes, or problematic trends, specifically regarding protocol requirements Protocol Coordination: Assists in the preparation of regulatory and protocol-specific documents Edits protocol template documents to add site-specific language and confirms consistency across all protocol documents Helps to ensure proper and timely filing of protocol amendments, annual reports, and other regulatory documents to the IRB and NCI Tracks and manages IRB submissions Enters study coordinators progress notes Assists with study start-up and closure