An organized and motivated employee with excellent attention to detail in research, verbal & written communication skills, eager to apply time management and organizational skills in the clinical research community in order to deliver excellent customer satisfaction. Seeking opportunities to expand skills while combining sound knowledge of MS Office and Data analytics with medical terminology, clinical monitoring process, Protocol knowledge in Clinical Research and hands-on experience in providing therapeutic modalities for clients in need of physical therapy treatment.
CRA Highlights
- Extensive ICH GCP guidelines and FDA regulations training
- Maintain current study enrollment and progress data according to company SOPs.
- Review protocol compliance, focusing on inclusion/exclusion requirements
- Circulate draft protocol for review
- Design CRFs and Send draft CRFs for review.
- Review CRFs and compare to source documents
- Submit request for investigational drug supplies.
- Participate in development of informed consent forms.
- Obtain investigator identifier numbers
- Coordinate investigator meeting/start-up dates with field monitors.
- Send study package(s) to field monitors (Protocol, Brochures, Consents, 1572, contracts/agreement letters, etc.)
- Ship clinical supplies to investigative sites.
- Confirm receipt of clinical supplies with each site
- Monitor site visits reports for any required action.
- Visit sites as scheduled