Protocol Nurse Coordinator II - NIH / NIAID

BioSpace; Bethesda (MD); Hybrid; USD 95,000 - 136,000; Full time

Job summary

Leidos Biomedical Research, Inc. is seeking a registered nurse to provide protocol management and regulatory support within the Clinical Research Directorate at NIH in Bethesda.

The role supports domestic and international trials across cancer, infectious diseases, and translational science, with telework on an ad hoc basis. The position requires an RN license, a bachelor’s degree in a related field, and experience in clinical trial operations, ICH/GCP knowledge, and regulatory documentation.

Qualifications

• Bachelor’s degree in a related field (CHEA-equivalent).
• Minimum 2 years of progressively responsible experience managing clinical research protocols.
• Current RN license in any U.S. state.
• CPR certification or eligible.
• Ability to obtain security clearance.
• Knowledge of ICH/GCP guidelines and clinical research concepts.
• Proficient with word processing and spreadsheet tools.

Responsibilities

• Provide protocol management to assigned caseloads of research protocols.
• Assist with clinical protocol development and ensure regulatory compliance.
• Develop protocol manuals and oversee protocol operations for study compliance.
• Coordinate patient enrollment, consent, eligibility, and referrals.
• Communicate with patients and providers about protocols and enrollment.
• Collaborate across a multidisciplinary team and train staff as needed.

Skills

Organizational skills

Interpersonal skills

Problem-solving

Clinical protocol experience

Education

Bachelor’s degree in related field

Tools

Word processing

Spreadsheets

Job description

Job ID: req4719

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., the Clinical Research Directorate (CRD), various clinical support teams provide high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CRD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides nursing support services for clinical research being conducted at clinics within the National Institutes of Allergy and Infectious Diseases’ (NIAIDs) Division of Intramural Research's (DIR), Laboratory of Immunology and Microbiology (LCIM).

Key Roles/Responsibilities

Provides protocol management to an assigned caseload of research protocols (including, but not limited to).

• Assists with clinical protocol development
• Ensures compliance with regulatory requirements
• Develops protocol procedure manuals
• Manages clinical protocols
• Obtains consent and facilitates clinical trial enrollment
• Confirms eligibility of volunteers for participation in clinical trials
• Communicates with patients and referring providers about the protocol and enrollment process
• Coordinates the new patient referral, enrollment, and admission process
• Oversees protocol operations to ensure study compliance
• Monitors data trends and alerts study team
• Problem-solves protocol violations
• Visits study site locations (intramural and extramural) as needed
• Coordinates research specimen procurement and processing
• Ensures regulatory compliance
• Completes and submits required regulatory documents in a timely manner
• Interfaces with NIH IRB to ensure timely filing of required reports
• Assists clinical staff with clinical implementation of the protocol
• Work collaboratively in a multi-disciplinary environment
• Appropriately delegate clinical and research tasks
• This position is not credentialed for patient care
• Trains staff (intramural and extramural)
• Creates and provides protocol initiation and update trainings
• This position is located in Bethesda, MD with telework ad hoc

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
• In addition to the education requirement, a minimum of two (2) years of progressively responsible experience including managing clinical research protocols or directly related work
• 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 organizational and planning, problem-solving, and interpersonal 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 perform word processing and spreadsheet applications independently with accuracy and speed
• General knowledge of biological principles and scientific methods
• Ability to obtain and maintain a security clearance

Preferred Qualifications

• Masters preparation in nursing, research, or a related discipline
• Prior experience in adult clinical trials management
• Knowledge and experience with clinical care or research trials in patient populations with immune deficiencies or infectious diseases
• Experience in transplant or gene therapy clinical management principles

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

95,100.00 - 136,400.00 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