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Dec
2
SCCR GCP Workshop: PI and CRC Responsibilities
By Susan Saba, Lead Coordinator of Education and Athletics Research, Stanford Center for Clinical Research (SCCR)

The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff.  We have invited the Clinical Research Director of Emergency Medicine, Leonard Basobas, partnering with SCCR’s Clinical Associate Director of Education and Training, Kiera Davis, MS, RN, BSN, to jointly present you with the clinical research responsibilities of the Principal Investigator and clinical research coordinator. Good Clinical Practice, FDA and HHS regulations will be presented, along with practical, real-world case studies for content application.

 

At the conclusion of this class, you will be able to:

 

·         Describe the role of CRC and PI according to regulations and GCP Guidelines

·         Understand the concepts of delegation of authority (DOA) and scope of practice

·         Outline the clinical research ecosystem

·         Define study roles and responsibilities

·         Understand the incorrect DOA

·         Learn DOA best practices

 

Attendance is open to all research staff

About the Instructor:

Kiera Davis, MS, RN, BSN, is the Associate Director for Education and Training at SCCR, working to improve clinical research education and training across the School of Medicine. Kiera also functions as the Program Management Office (PMO) Lead, providing oversight and guidance to SHC Tri-Valley as they expand the research enterprise in the East Bay. Kiera has over 10 years of research experience and has worked at Stanford for the last 7 years, previously working as a pediatric cardiac intensive care nurse.

Leonard Basobas, MS, is currently the Director of Growth & Development for the Emergency Medicine-Clinical Research Unit (EM-CRU) at Stanford University. He has over 20 years of experience in the field of Clinical Research, he was a Sr. Research Manager at Stanford Center for Clinical Research (SCCR), and a Study Lead, Sr. Project Manager at various academic institutions, Contract Research Organizations (CROs), large health care systems, and in the private sector. Leonard has extensive experience successfully building and managing cross-functional teams, and training and developing staff in accordance with Good Clinical Practice and federal regulations.

 

BRN OPTIONAL

Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 1.5 contact hour(s).

 

To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.

BRN Cancellation Policy: If you wish to cancel your registration, please contact Susan Saba at ssaba@stanford.edu.