Clinical Research Nurse III - NIH/ NIAID

BioSpace; Bethesda (MD); On-site; USD 87,000 - 145,000; Full time

Benefits offered by this job

Health and Wellness programs

Income protection

Paid leave and retirement

Job summary

Leidos Biomedical Research, Inc. seeks an experienced clinical research professional to support NIH protocols at the Frederick National Laboratory.

You will coordinate patient enrollment, consent, and study visits while ensuring regulatory and data integrity and collaborating with multidisciplinary teams. Qualified candidates bring RN licensure, 5+ years of nursing/clinical experience, and strong communication skills.

Qualifications

• Bachelor’s degree or 4 years relevant experience in lieu of degree.
• Minimum of five (5) years of recent nursing/clinical experience.
• Current unencumbered RN license in any U.S. state.
• Ability to wear PPE and CPR certification or certifiable.
• Strong planning, problem-solving and interpersonal skills.
• Excellent organizational, computer, and communication skills.

Responsibilities

• Provide clinical support to assigned caseload of research protocols.
• Recruit patients for clinical protocols and screen referrals.
• Communicate with patients and providers about protocols and enrollment.
• Obtain informed consent and coordinate study visits and labs.
• Manage protocol data, organize study files, and maintain databases.
• Ensure regulatory compliance and assist with protocol training materials.

Skills

Clinical research coordination

Patient communication

Regulatory documentation

Protocol compliance

Data management

Education

Bachelor’s degree

RN license

Tools

REDCAP

iMED

MS Office

Job description

Job ID: req4747

Employee Type: exempt full-time

Division: Clinical Research Directorate

Facility: NIH

Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 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. (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 coordination and support of the overall functions of the National Institute of Allergy & Infectious Diseases (NIAID), Division of Clinical Research (DCR), Intramural Clinical Management and Operations Branch (ICMOB).

Key Roles/Responsibilities

Provides clinical support to an assigned caseload of research protocols (including, but not limited to):

• Recruits patients for clinical protocols
• Screens referrals
• Communicates with patients and referring providers about the protocol and enrollment process
• Documents screening activities in appropriate databases
• Assists in determining eligibility of volunteers for participation in clinical trials
• Obtains informed consent for clinical trial participation
• Interacts with patients and protocol participants during clinical and protocol visits
• Triages patient concerns and medical conditions
• Understands study protocols and ensures clinical activities are performed in accordance with protocol requirements
• Handles research samples, collects and delivers them
• Coordinates and schedules patients’ study protocol visits
• Schedules required labs, diagnostic tests, consults
• Updates system calendars with patient schedules
• Works with the travel team to arrange patient travel and lodging
• Communicates study schedule and visit requirements to patients
• Obtains consents for the release of medical records
• Facilitates the procurement of outside medical records and materials
• Organizes, files, and reviews outside medical records
• Coordinates research specimen procurement and processing
• Obtains consent for send in samples
• Assists with specimen procurement procedures
• Logs received samples in appropriate databases
• Processes outside material through the appropriate NIH departments
• Assists in the coordination and implementation of clinical trials
• Manages and analyzes protocol data
• Organizes study files
• Maintains databases
• Assists with the monitoring of and compliance with regulatory requirements
• Assists with the creation and preparation of protocol training materials
• Works collaboratively in a multidisciplinary environment to assist clinical staff with clinical implementation of the protocol

This position is credentialed for the corresponding level of patient interaction required for the role

This position is full-time on-site at the NIH Clinical Center in Bethesda, MD during regular clinic hours Monday - Friday, excluding Federal holidays. Ad hoc telework available as determined by clinical and protocol needs

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. Additional qualifying experience may be substituted for the required education
• In addition to educational requirements, a minimum of five (5) years of recent nursing/clinical experience
• Possession of a current unencumbered professional license as a Registered Nurse (RN) from any U.S. state
• Ability to wear personal protective equipment
• Must be CPR certified or certifiable
• Highly effective planning, problem-solving, and interpersonal skills
• Highly effective organizational, computer, and communication skills
• Working knowledge of biological principles and scientific methods
• Working knowledge of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, clinical research concepts, ethics, processes, and clinical protocol implementation
• Ability to obtain and maintain a security clearance

Preferred Qualifications

Candidates with these desired skills will be given preferential consideration:

• Prior clinical research and clinical trial experience, including data collection, data management, and study documentation
• Experience conducting participant assessments and follow-up, including documentation and communication of relevant findings to clinical and research staff
• Experience with clinical protocol implementation, regulatory documentation, and protocol compliance
• Experience in the fields of infectious diseases, allergy, immunology, autoimmunity, and/or chronic disease processes
• Proficiency using electronic research and clinical systems, including platforms such as iMED, REDCAP, Electronic Data Capture Systems, research databases, and Microsoft Office applications (Word, Excel, Outlook, PowerPoint)

JOB HAZARDS

This position is subject to atmospheric conditions that would require the usage of a respirator, requiring a medical clearance

This position is subject to working with or has the potential for exposure to infectious material, requiring medical clearance and immunizations

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

86,500.00 - $145,000.00 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