Job ID: req4394
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 remote clinical research staff. This team provides remote, centralized support to U.S. NCI research sites, including 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 activities, such as subject screening, enrollment, and data entry.
This position is 100% remote. Candidates must reside in the U.S. or a U.S. territory.
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:
- 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 organizes and files those materials.
- Reviews participant materials to appropriately advise local teams on potential participant eligibility for protocols.
- Assists in the informed consent process.
- Documents screening and enrollment activities in designated databases (e.g., NCI Oncology Patient Enrollment Network, also known at OPEN; internal tracking files).
- Participant Management:
- Assists with visit/procedure scheduling, including protocol-defined long-term follow-up.
- Provides follow-up visit reminders to participants.
- Assists with participant retention efforts.
- Reviews medical records to identify concomitant medications (con-meds) and adverse events (AEs)/unanticipated problems/serious adverse events (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.
- Assists with visit/procedure scheduling, including protocol-defined long-term follow-up.
- 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, etc.) and clinical trial management systems (e.g., OnCore, Florence e-Reg, Velos eResearch, Complion, etc.) in a timely and accurate manner, to ensure data integrity.
- Tracks and confirms source materials (e.g., images, path, etc.) and submits 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 maintains consistency across all protocol documents.
- Assists with 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.
- Assists in the preparation of regulatory and protocol-specific documents.
- Collaboration:
- Works collaboratively with VCTO team members, site staff, and data monitors to meet program and protocol requirements, deadlines, and deliverables.
- Updates and/or maintains tracking tools to ensure protocol and program milestones are met in a timely manner.
- Effectively tracks and accurately presents the status of assigned tasks at team meetings and other reporting periods.
- Participates in virtual meetings with the clinical care teams at various clinical sites to review clinical research protocols, procedures, and reports.
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 educational requirements, a minimum of two (2) years of progressively responsible, relevant nursing experience in oncology clinical research, the concurrent management of multiple customers and tasks.
- Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state.
- CRN II:
- Competent clinical research nursing experience in adult oncology.
- Intermediate 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.
- Competency with:
- Cloud-based clinical trial data management systems (e.g., 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, etc.)
- Online/virtual platforms (e.g., Webex, Zoom, Microsoft Teams)
- Highly effective:
- Interpersonal and cross-cultural communication skills (e.g., 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.
- Additional role-specific requirements:
- Ability to work effectively, both independently and collaboratively, with team members to track work 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:
- NCI's National Clinical Trials Network (NCTN) trials.
- Performing user acceptance trainings.
- Epic, Cerner, OPEN, Medidata Rave, OnCore, Velos eResearch, and Complion.
Nationally accredited certification in:
- Oncology Nursing
- 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
74,800.00 - 128,625.00 USD
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