Clinical Research Nurse III

Job ID: req4287

Employee Type: exempt full-time

Division: Clinical Monitoring Research Program

Facility: Telework: US

Location: USA

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.

Program Description

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.

Key Roles/Responsibilities

Provide remote clinical research nursing support to an assigned caseload of research protocols and research sites. Duties include, but are not limited to:

• 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
  

Basic Qualifications

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Possession of a Bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a related field. Foreign degrees must be evaluated for U.S. equivalency.
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state.
• In addition to educational requirements, a minimum of five (5) years of progressively responsible, relevant nursing experience in clinical research, including directly managing multiple concurrent projects and patient data systems, as well as an advanced understanding of clinical trial protocol operations and design.
• Advanced to expert clinical research nursing experience in adult oncology.
• Working knowledge and understanding of:
• Biological principles and scientific methods
• International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, regulatory, ethics, processes, and clinical protocol implementation
• Cancer pathophysiology, treatment modalities and side effects
• Technical proficiency using:
• Cloud–based clinical trial data management systems (i.e., Medidata Rave) and enrollment tracking systems (e.g., OPEN)
• Electronic health record systems (e.g., Epic, Cerner, etc.)
• Microsoft Office products (e.g., Excel, Word)
• Online/virtual platforms (e.g., Webex, Zoom, MS Teams)
• Highly effective:
• Interpersonal and cross-cultural communication skills (written, verbal, non-verbal, and virtual)
• Organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
• Planning, and problem-solving skills
• Computer skills
• Ability:
• Ability to work effectively, both independently and collaboratively, with ability to motivate team members, track progress, and contribute to the team’s performance
• Identify trends and appropriately escalate findings
• Demonstrate strong initiative, accountability, and reliability
• Multidirectional leadership
• Manage customer relationships
• Troubleshoot basic IT problems
• Ability to obtain and maintain a security clearance.
  

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Prior experience with:
• Study coordination
• NCTN trials
• Performing user acceptance trainings
• Epic, Cerner, OPEN, Medidata Rave, OnCore, Velos eResearch, Complion
• Professional Certification in Oncology and Clinical Research
  

Commitment to Non-Discrimination

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, color, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

Pay And Benefits

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here

82,300.00 - 141,500.00

The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.

The salary range posted is a full-time equivalent salary and will vary depending on scheduled hours for part time positions