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Protocol Monitoring Specialist

  • Location: Bethesda, MoCo, Maryland
  • Job Type:Contract

Posted 12 days ago

  • Sector: Government
  • Start Date: 2022-05-04
  • Job Ref: 22-09390
Overall Position Summary and Objectives The Gulf War Illness program at NINDS requires a protocol monitoring specialist to serve as an expert in providing quality assurance and compliance oversight to the research team. This position will liaison with the NINDS Quality Assurance and Data Management (QADM) Office and assist with tasks within the NINDS Division of Intramural Research.
 
Minimum Education
Master's
 
Certifications & Licenses
  • Clinical Research Associate (CRA)
 
Skills (Ranked By Priority)
  1. SOPs
  2. Site monitoring
  3. Data Monitoring
  4. Regulatory compliance
  5. Data Integrity
  6. Regulatory affairs
 
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
 
Software
  • Electronic Medical Records System
  • Electronic Data Capture System
Field of Study
  • Health and Medical Administrative Services
  • Run Validation - Quarterly
  • Meet with lab members to present updates – Weekly
 
Provides assistance in the regulatory oversight, fiscal and operations management of new clinical trial protocols preparation.
  • Assist in the preparation of new clinical trial protocols.
  • Serve as a Clinical Trials Specialist, with responsibility for carrying out administrative and information management functions for clinical trials and related research being conducted within the section.
Coordinates submissions of all new clinical trial protocols to multiple regulatory agencies.
  • Work with staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing.
  • Collaborate with staff on initial submissions, continuing reviews, amendments, audits and other administrative requirements.
Develops database to track all clinical trial documents, report submissions, review submissions, etc.
  • Distribute and track all new clinical trial protocol documents to the protocol development team to ensure proper document control, through the initial draft until the final version prior to the start of a study.
  • Use and revise/create data capture forms to meet study needs.
  • Track, organize and generate analyses and reports using available databases for evaluation of project needs.
Monitor clinical trial progress.
 
  • Conduct site visits to monitor clinical trial progress.
  • Validate required documentation is being maintained.
  • Review site visit findings with investigator.