Personal Information
Unternehmen/Arbeitsplatz
San Francisco Bay Area United States
Beruf
Sr. CRA at Biomarin Pharmaceutical
Info
Motivated and performance driven RN with 15+ years of experience in clinical research (clinical operations, regulatory, drug safety), project management, and data management. Extensive experience coordinating and managing 30+ Phase I-IV medical device and drug trials, including site initiation and management, data review and verification, data management, IRB and FDA submissions, and adverse event reporting and resolution. Highly skilled at medical writing (i.e. study protocols, ammendments, safety narratives, clinical study reports, informed consent forms/ assents, literature summaries, and regulatory documents).
Therapeutic Indications: Rare Diseases (MPS), Oncology, Neurology, GI, Li...
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(1)Personal Information
Unternehmen/Arbeitsplatz
San Francisco Bay Area United States
Beruf
Sr. CRA at Biomarin Pharmaceutical
Info
Motivated and performance driven RN with 15+ years of experience in clinical research (clinical operations, regulatory, drug safety), project management, and data management. Extensive experience coordinating and managing 30+ Phase I-IV medical device and drug trials, including site initiation and management, data review and verification, data management, IRB and FDA submissions, and adverse event reporting and resolution. Highly skilled at medical writing (i.e. study protocols, ammendments, safety narratives, clinical study reports, informed consent forms/ assents, literature summaries, and regulatory documents).
Therapeutic Indications: Rare Diseases (MPS), Oncology, Neurology, GI, Li...