Stephanie Tanimoto Mcchesney, Ccrp Email & Phone Number

California, United States

San Francisco Bay Area

San Francisco Bay Area

Provide a full range of services to prepare Pharmaceutical and Medical Device companies for regulatory communications, from submissions to FDA advisory committee meetings and EMA and CHMP. Review scientific data and clinical trial results; develop communication strategy and key messaging for market approval; develop communication deliverables such as scripts, presentations, and Q&A; key opinion leader research and engagement; test strategy and submission through expert panels and manage communication rehearsals for FDA advisory committee and EMA/CHMP meetings.

Santa Barbara, California Area

• Supporting clinical trials under the guidance of Good Clinical Practices (GCP's) and Standard Operating Procedures (SOP's). Site selection and development, scientific education, hands on training of investigators on study product and operating room observations • Educate and train physicians, hospital personnel and staff on technical matters related to investigational products and procedures through one-on-one training, structured in-service education programs, and cadaver labs• Facilitate the flow of scientific information to and from the SERI® R&D/Product Development teams, medical affairs, through direct physician visits, conference attendance, and Operating Room experiences. Provide feedback on device iterations and new device development • Assisted in development and presented operating room best practice presentation R&D and Clinical Product Development teams at time of product launch• Responsible for the clinical development function in product development for SERI® LIGHT• Provide extensive operating room and physician interaction experience to:- Develop clinical protocols (SURE-001, and SURE-002)- Develop materials for investigators and clinical staff- Troubleshoot clinical issues to determine root cause and develop control strategies- Input relevant clinical information into FMEA (SURE-001, and SURE-002)• Technical understanding of anatomy and surgical procedures related to SERI® Surgical Scaffold• Manage investigational inventory to include storage at device/protocol determined temperatures, product expiration dates, and initiate shipments and returns of investigational products according to protocol and company guidelines

Santa Barbara, California Area

Santa Barbara, California Area

St. John'S Hospital, Oxnard, Ca

The Clinical Care Extender Internship features a clinically-focused experience that gives pre-health professionals unprecedented access to direct patient care. Clinical Care Extender Interns are valuable members of the patient care team alongside nurses, physicians and allied health professionals in clinical and administrative settings. Receive training to participate in basic patient care tasks such as bathing, changing and feeding patients and rotate among the different departments within the hospital. Serve in areas such as the Emergency Department, observe surgeries performed in the Operating Rooms and witness babies being born in Labor & Delivery.

Ba, Cultural Anthropology, Dean'S List

Activities and Societies: UCSB Triathlon Team

Cultural Anthropology

Spent a full year studying in Australia through UCSB's education abroad program