Smita S. Email & Phone Number

San Jose, California, United States

San Jose, California

Sr. Clinical Research Associate - DEC 2018 - FEB 2020Clinical Research Associate - SEP 2017 to FEB 2019- Assist CRA with monitoring on class II medical device clinical studies (focus groups, feasibility, pivotal)- Create & update budgets and timelines to ensure project is delivered on time & within scope- Serves as a liaison for study sites, investigators, and coordinators- Conduct site training on GCP, HSP, ICH guidelines and study protocol- Work with cross-functional teams to discuss clinical study strategy and plan- Draft protocols, data case report forms, informed consents, investigator brochures- Prepare and submit IRB and Ethics Committee applications for global clinical studies- Write FDA/EC annual and final reports for global clinical studies- Oversee and manage student intern- Assist in managing Summer Intern Program- Work with Clinical Affairs team to create updated standard operating procedures and templates- Conduct team meetings with cross-functional teams and send out meeting minutes- Conduct site evaluation visits & site initiation visits to evaluate potential investigators

San Jose, Ca

Division Of Vascular And Endovascular Surgery

- Coordinated investigator-initiated and industry-sponsored clinical research studies in accordance with FDA regulations, ICH guidelines, and GCP standards at three sites (UCSF, SFVA, ZSFG) for class II, and III medical devices and phase III and IV drug studies- Prepared Institutional Review Board (IRB) submissions including informed consent forms, serious adverse events, protocol deviations, annual renewals, and amendments- Assisted with study start up and close out, including budgets and contracts- Configured and managed study databases for investigator-initiated studies- Analyzed study data using Stata for investigator-initiated studies- Managed and ensured proper storage of lab samples including blood, cerebral spinal fluid, & urine

San Francisco, Ca

- Acted as the primary contact for patients and surgeons- Scheduled new patients and follow-up using Apex and Apollo systems- Utilized OpTime to accurately schedule cases, instruct patients on surgical processes- Verified insurance and obtaining prior authorizations for appointments and surgeries- Knowledge and understanding of ICD-9 and ICD-10 diagnosis and CPT procedure coding

Santa Monica, Ca

San Jose, Ca