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"Serving Research Worldwide"
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Are you looking for the best service that an Independent Clinical Research Consultant can provide? Are you tired of being promised the world, yet find your project comes in second behind the "bigger guys"?
If so, you've come to the right place...because I care.
Let me provide you with the best service available in Clinical Research Trials.
I've worked as a regional Sr. CRA, project manager, field trainer and auditor.
My primary goal is to provide the highest quality services to the pharmaceutical, biotechnology and medical device companies.
Because I care about the client, the patients, and the integrity of the data, you can rest assured that your clinical trial will have my undivided attention!
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Profile: Symanthia Robertson
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Diligent, conscientious, detail-oriented Pharmaceutical Research Consultant with over five years of extensive experience in field monitoring and auditing clinical trials; Over three years of experience training new CRAs and site personnel; Established home-based office in Raleigh, NC; Interested in regional clinical consulting opportunities with pharmaceutical, biotechnology or medical device companies.
Education:
BA, Biology, UNC-Wilmington, NC
Beginner through Advanced CRA Training Courses
Experience:
* Participates in aspects of monitoring and project management of Phase III pharmaceutical and biological/device studies, including collection of regulatory documentation, drug accountability, maintenance of protocol compliance and milestone timelines, data collection and review, Datafax, report generation and budgets
* Develops and implements training strategies, standards and educational programs for current and future CRAs, CRCs and investigators
* Serves as a project team resource for FDA regulatory advice and coaches teams in all areas of quality assurance
* Review and audits regulatory files and U.S. Investigative sites to ensure compliance with GCP/ICH guidelines
* Assists in development and revision of clinical and regulatory SOPs
* Recruited 200+ investigators; conducted 100+ pre-study, initiation and close-out visits
* Performed 300+ monitoring visits
* Interviewed and trained over 50 new CRAs
* Supervised and accompanied new CRAs on various study-related visits
* Managed multi-million dollar research projects
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