Protocol Monitoring Specialist
We are currently searching for 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. This is a full-time, on-site opportunity in Bethesda, MD.Duties & Responsibilities
- Track, organize and generate analyses and reports using available databases for evaluation of project needs.
- Conduct site visits to monitor clinical trial progress.
- Validate required documentation is being maintained.
- Review site visit findings with investigator.
- 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.
- 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.
- 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.
- Master’s degree in Health and Medical Administrative Services
- At least 3-4 years of experience
- Clinical Research Associate (CRA)
- Electronic Medical Records System
- Electronic Data Capture System
- Site monitoring
- Data Monitoring
- Regulatory compliance
- Data Integrity
- Regulatory affairs
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
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