Roberta Vezza Alexander
Protocol Development Officer @UC San Diego Health
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WORK HISTORY
Protocol Development Officer @UC San Diego Health
San Diego, CA, US
Developed protocols and study materials for investigator initiated trials (IIT) at the Moores Cancer Center of the University of California San Diego Health Sciences with particular focus on oncology interventional studies.Wrote study protocols, protocol amendments, laboratory and pharmacy manuals, questionnaires, monitoring plans, and informed consent forms (ICF) in collaboration with investigators, statisticians, regulatory and quality assurance personnel, pharmacists, and project managers, to secure approval by internal IRB and other regulatory bodies overseeing clinical research.Registered trials and entered results in clinicaltrials.gov.
EDUCATION
University of Pennsylvania
Post Doctoral Fellow in the School of Medicine, Molecular Pharmacology
UC San Diego
Good Clinical Practices (GCP)
Università degli Studi di Perugia
Doctor of Philosophy (PhD), Molecular Pharmacology
Università degli Studi di Perugia
Doctor of Pharmacy (PharmD), Pharmacy
SKILLS
ABOUT ROBERTA VEZZA ALEXANDER
Senior Clinical Research Leader and Pharmacologist with experience in academia, diagnostics, and drug discovery industries. Experience in multiple therapeutic areas (oncology, rheumatology, gastroenterology, pain, endocrinology, inflammation, cardiovascular disease) and unique background encompassing medical writing, clinical and preclinical research, medical affairs, scientific communication, medical needs assessment, target identification, evaluation of business development opportunities, and assay development. Developed protocols, consent forms, and other material for investigator initiated trials (IIT) and industry sponsored studies. Provided scientific and clinical guidance to cross-functional teams. Planned, implemented, managed, and monitored multi-site clinical studies to demonstrate clinical validity and clinical utility of diagnostic tests. Interacted with key opinion leaders (KOLs) to design and interpret results of clinical studies, and to identify unmet medical needs.Evaluated scientific literature for pipeline expansion and performed dry assessment and wet feasibility work. Developed, planned and implemented experiments to support feasibility, lead discovery, and lead optimization projects, and communicated research progress to company management to enable go-no-go decisions.
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