John Staton Email & Phone Number

Santa Clara, CA, US

San Diego, CA, US

Orchestrated as Clinical Affairs' Program Lead the global execution of analytical (reproducibility) and clinical validation testing for company’s next generation sequencing companion diagnostic programs with pharmaceutical partners.Served as Clinical Affairs representative in Core Team structure and Joint Development Committees with external partners and.

San Diego, CA, US

Clinical Affairs’ Program Lead overseeing validation programs for company’s next generation sequencing companion diagnostic programs with pharmaceutical partners. Clinical Affairs' representative in Core Team structure and Joint Development Committees. Line manager to Clinical Study Managers and Clinical Research Associates.

Bethesda, MD, US

Primary point of contact for client and cross functional teams to ensure timely execution of clinical trials. Global Clinical Lead for Phase 2/3 US and international studies (Americas, Europe and Asia/Pacific regions) in rare disease and reproductive health. Worked closely with KOLs and patient advocacy organizations to generate awareness for rare disease.

Morrisville, North Carolina, US

Clinical Lead and Clinical Research Associate for Phase 1/2 US and internationalstudies in hematologic and solid tumor malignancies.Performed on-site monitoring (SQV, SIV, IMV, COV) per study guidelines, WIs and SOPsTherapeutic experience: Oncology studies - Multiple Myeloma, Waldenstrom Macroglobulinemia, Solid TumorPulmonary: Chronic Obstructive.

Performs and coordinates the clinical monitoring activities in accordance with GCPs and Cato's SOPs. Ensures compliance of clinical trials with federal and local regulatory requirements.Conducts site evaluation, initiation, periodic and termination monitoring visits to determine protocol and regulatory compliance, and prepares required documentation.Drafts.

Coordinated and tracked project team activities, coordinated and attended project team and sponsor meetings.Managed and coordinated clinical trial activities; advised project leader on the status of outstanding issues.Prepared meeting minutes and action items; prepared and tracked project schedules, project budgets, and team personnel.

Laboratory Manager:Oversaw administrative responsibilities of 12-member immunology laboratory.Managed laboratory finances, ordered/inventoried supplies and reagents, established and maintained vendor/supplier relations, maintained laboratory license and regulatory documents, and conducted annual safety reviews.Supervised radioactive and hazardous material.