Certifications & Licenses
- Clinical Research Associate (CRA)
Skills (Ranked By Priority)
- Site monitoring
- Data Monitoring
- Regulatory compliance
- Data Integrity
- Regulatory affairs
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
- Electronic Medical Records System
- Electronic Data Capture System
- 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.
- 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.
- 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.