Remote Research Nurse Administrator (RN) – (NIH / NCI)

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., 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 Research Support (VRS) program. The program 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.

KEY ROLES/RESPONSIBILITIES

• Serves as the lead to supervise and manage the CMRPD Virtual Research Support team, which will include study coordinators and data entry/analyst positions
• Assists with identifying and selecting U.S. NCI research sites to participate in the VRS initiative
• Drafts and implements manual of procedures (MOP) and educational module to address VRS project goals establish best practices and systems that are scalable for potential expansion of VRS activities
• Identifies and implements additional opportunities to further minimize the research burden on the clinical site research staff and study participants
• Trains and manages the VRS team, provide back-up support as needed
• Coordinates engagement with clinical site research staff, facilitates access to institutions’ electronic health records, support reporting of clinical trial data
• Screens patients to identify potential candidates for participation in NCI-sponsored clinical trials
• Identifies labs and procedures that may be required to address eligibility criteria
• Supports and performs the informed consent process
• Works with site local physicians to facilitate enrollment and follow up visits of participants into clinical trials
• Works with clinical site staff to coordinate care and provide education on research needs/requirements and VRS procedures
• Alerts physicians to adverse events, abnormal outcomes, or problematic trends, specifically in regard to protocol mandates
• Coordinates various activities to ensure proper and timely filing of serious adverse events, protocol amendments, annual reports, and other regulatory documents to the FDA, IRB, and NCI
• Monitors overall progress of VRS remote staff support to institutions, assignments, and timeliness
• Assists with VRS project evaluation and oversight
• Ensures quality of clinical trial data reporting
• Supports data abstraction from the local Electronic Health Record (EHR) into the NCI Clinical Data Management System (Medidata Rave); identify barriers to access both systems
• Coordinates study visits and procedures, provide reminders, report adverse events, and address participants’ questions in a timely manner
• This position is 100% remote

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 in nursing from an accredited college or university according to the Council for Higher Education Accreditation (CHEA).  Foreign degrees will be evaluated for U.S. equivalency
• 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 license as a registered nurse (RN) in a U.S. state
• In addition to educational requirements, a minimum of five (5) years nursing and/or related clinical research experience and three (3) years staff and project management 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, capturing and analyzing trial participants’ data, including toxicity assessment, drug administration, laboratory results, and tumor response
• Experience managing all facets and all phases of clinical trials
• Understanding of the Department of Health and Human Services (DHHS) regulations for the protection of human research participants
• Effective verbal and written communication skills, with demonstrated experience using online communication platforms such as email, virtual meeting software, chat rooms, messaging apps, and dedicated office software
• Experience creating and running virtual meetings using various online meeting platforms
• Strong interpersonal and cross-cultural communication skills
• Knowledge and understanding of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, regulatory, ethics and other requirements for domestic and international studies
• Expertise in analysis, planning, and problem solving
• Strong organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
• Ability to work effectively, both independently and as a team leader, with ability to motivate team members, manage timelines, track progress, and contribute to the team’s performance
• Demonstrated proficiency in Windows ® and Microsoft ® Office Suite including Word ®, Project ®, and Outlook ®, as well as MS Teams, Zoom, WebEx and/or other online communication platforms
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• Clinical research oncology experience
• Demonstrated leadership skills in a clinical research setting
• Experience with case report form completion/data collection for clinical trials
• Familiarity with Federal Acquisition Regulations (FAR)
• Knowledge of cloud–based clinical data management systems, particularly Medidata RAVE
• Knowledge and understanding DHHS regulations related to federally funded studies
• Understanding of regulatory filings with FDA and institutional review board (IRB) processes
• Experience working with multiple clinical research sites
• Experience overseeing or working with subcontracted clinical sites
• Ability to work in a remote environment while virtually managing, training, and motivating team members
• Experience in a clinical trials outpatient setting and/or experience in data management and collection
• Demonstrated success deploying and implementing projects and processes

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