Address
Form of workJob Description
Work Location: IC: NINDS Street: 10 Center Dr Bldg: 10 Room: 2A23 City:Bethesda State & Zip: MD 20814
Weekly Hours - FT: 30-40 hours per week
Payrate - $56.65 hourly on W2
Overall Position Summary and Objectives
The primary role for this Protocol Navigator (PN) position is to provide Clinical Research regulatory support through the NINDS Clinical Trials Unit (CTU) For the NINDS Intramural Research Program, including specific groups as assigned. This role is centered 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
Resume Max Pages- 3
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
Statement of Work Details
- 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.
- Collects, distributes and submits regulatory documents.
- Develops training plans and trains staff on the proper techniques for protocol submission.
