Job Title - Clinical Research Protocol Navigator
Location - Bethesda, Maryland

The primary role for this Protocol Navigator (PN) position is to provide clinical research regulatory support through the Intramural Research Program, including specific groups as assigned. This role is centred around clinical research protocol and informed consent document development and requires expert writing skills. This role also includes IRB submissions, regulatory document management, amongst other regulatory study tasks.

Min Education- Master's

Certifications & Licenses :

- Association of Clinical Research Professionals Certified Professional (ACRP-CP)

- Association of Clinical Research Professionals (ACRP)

- Certified Clinical Research Professional (CCRP)

- Certified Clinical Research Coordinator (CCRC)

- Certified Clinical Research Associate (CCRA

Field of Study-

• Miscellaneous Health Medical Professions
• Nursing
• Biology
• Multi-Disciplinary or General Science
• Health and Medical
• Preparatory Programs
• General Medical and Health Services
• Neuroscience
• Health and Medical Administrative Services
• Cognitive Science and Biopsychology
• Miscellaneous Biology

Software-

- Clinical Trial Management System (CTMS)

- Electronic Medical Records System

- Electronic Data Capture System

Skills:

- Liaising with regulatory authorities

- Training clinical trial site staff

- Previous clinical trial work

- Phase I or II experience

- Regulatory compliance

- Protocol development

- Protocol navigation

- Regulatory affairs

- Clinical Research

- IRB submissions

- Clinical Trials

- On-site visits

- Data Integrity

- Research

- ICH/GCP

- Strong writing skills with experience writing clinical research protocols

Assists researchers with protocol development, assembly and review of clinical trial documents.
Assists researchers develop and maintain trial related documents and operational procedures.
Maintains study databases and conducts basic analysis.
Assists researchers collect, distribute and file regulatory documents.
Provides technical support to researchers and the clinic.
Develops and assembles clinical trial documents.
Develops and maintains trial related documents and operational procedures.
Collects and distributes regulatory documents.
Develops, assembles and reviews clinical trial documents.
Collects, distributes and files regulatory documents.
Reviews and recommends changes to clinical trial documents.
Reviews and maintains trial related documents and operational procedures.