My main role is to provide oversight of Serious Adverse Event (SAE) reporting for all company clinical trials, review of all safety-related documents. I facilitate remote medical monitor review and oversee our Pharmacovigilance Vendor (case processing, DSUR reporting, and negotiation of cost savings) amoung other responsibilites related to clinical trial management and drug safety.

Clinical Research Associate with responsibility to ensure that all safety reports received from investigators and business partners are processed and reported according to ICH-GCP guidelines, and provide general oversight for safety needs for the clinical department.

Assist in transitioning acquired compounds and information from CVT to Gilead. Including training of Gilead personnel on CVT compounds and the Argus system.

Process adverse event (AE) reports from post-marketing and clinical trials to ensure timely reporting to regulatory agencies. Provide safety input on Phase I-IV clinical trial protocol development, study management, and CRF design. Conduct SAE management and reconciliation.

Liaison between Research and Development (R&D) and Johnson & Johnson (J&J) Global Clinical Operations, compound development and planning for clinical development, development and writing of clinical protocols. Lead the research teams in Phase I-IV protocol design, overseeing the trial execution either by managing the Contract Research Organization (CRO) or by providing monitoring (initiation through closeout), assisting in the development of the clinical study report, and supporting the submission to the regulatory authorities.

In-house client support activities of clinical studies for Clinimetrics’ clients, including safety monitoring, regulatory document collection and tracking, database review, and tracking of monitoring visits.

Recruited, tracked and coordinated visit schedules, subject follow-up, study documentation including source documents and CRFs, AE/SAE documentation, overseeing drug accountability, sponsor communication, coordination of monitoring visits, query resolution.

Home Care Nurse/Pediatric Case Manager - Stanford Home CareHome Care Coordinator/Discharge Planner - Stanford Home Care/Lucile PackardPediatric Intensive Care Nurse - Lucile Packard Children's Hospital PICU