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.

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.

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.

Santa Monica, CA

San Jose, CA