2-part GCP Bootcamp – 2 consecutive Fridays
Part 1: Friday April 28  from 10:00 am to 4:00 pm
Part 2: Friday May 5, 2023

Stanford Research Office (Spectrum) and the Stanford Center for Clinical Research (SCCR) are hosting the second in-person GCP Bootcamp. This is a 2-part in-person workshop focused on GCP topics. It is designed to accelerate completion of Spectrum’s Clinical Research Operations Certification requirements and will include 5 core classes and 1 elective class from the Program. Included Classes are listed below. Lunch will be provided.

Registration Links

• Day 1 – April 28
• Day 2 – May 5

Registration Fee: $30 per day – STAP Funds Eligible

Note: Registration for Day 1 and Day 2 of the Bootcamp is independent. You must register for each day separately. The registration fee will only be refunded if you cancel by Friday, April 21st, 2023.

Day 1 – April 28

• General Reporting and IRB Reporting Requirements
• Study Team Roles & Responsibilities and DOA
• Adverse Events

Day 2 – May 5

• Informed Consent
• Good Documentation Practices
• Phases of Research & Types of Study Designs

By attending this workshop, you will:

• Introduced to principles of GCP and learn how to apply them
• Learn the importance of adhering to GCP principles
• Prepare for the Clinical Research Operations Certification Exam

Endorsed by: The Clinical Research Operations Program Advisory Committee with representation from:

• Cancer Clinical Trials Office (CCTO)
• Clinical Research Quality (CRQ)
• Maternal Child Health Research Institute (MCHRI)
• Office of Research Patient Care Services (ORPCS)
• Research Compliance Office (RCO)
• Stanford Center for Clinical Research (SCCR)

BRN Credit: Spectrum is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435. To receive BRN credit, you are required to complete an evaluation for each class presented during the Bootcamp. Maximum number of BRN credits offered is 8 CEUs. The cost for BRN credit is $35 per credit (total for 8 credits is $280) and may be paid via STAP funds. To register for BRN credits, choose the class code that ends in “BRN” on the registration page.

• Day 1 – CTR-3211-042823BRN
• Day 2 – CTR-3212-050513BRN

Note: The class registration fee of $30 per day is separate from the BRN credit fee of $35 per credit unit.

SPEAKERS 

Maya Berdichesky, DMD – Trial Innovation Network CTSA Hub Liaison Manager, Spectrum
Prior to joining Spectrum in 2021, Maya was the Quality and Compliance Manager at the Stanford Center for Clinical Research (SCCR) where she created and led the quality and compliance program for 5 years. Maya has been involved in clinical research for over 10 years, after making a career change from dentistry. Her research career at Stanford began in 2014 when she accepted a Regulatory position with the Stanford Pain Division. Maya’s current role with the Stanford Research Office is CTSA Hub Liaison Manager.

Jennifer Swanton Brown, RN, CCRP Director, Clinical Research Quality – Assistant Dean, Compliance, Regulatory Affairs, and Quality, School of Medicine
Jennifer joined Stanford University in 2006 as IRB Training Specialist and became Manager of Regulatory Services and Education for Spectrum as part of Stanford’s CTSA in 2008. Jennifer became the inaugural Director of Clinical Research Quality in March 2016, responsible to the Senior Associate Dean for Research in the School of Medicine. She has 30 years of experience in nursing, writing, training and education, and regulatory affairs, with emphasis in quality improvement and clinical trials.

Kiera (Larsen) Davis, MSCR, RN – Clinical Associate Director, Education & Training, SCCR – Program Lead, SHC-ValleyCare Program Management Office (PMO)
Kiera is the Clinical Associate Director, Education & Training in the Stanford Center for Clinical Research (SCCR). She transitioned to Stanford University in 2015 after working as a pediatric intensive care nurse from 2011-2015. She has 10 years of clinical research experience and is currently working to improve education and training for clinical research staff across the School of Medicine.

Haley Hedlin, PhD – Associate Director, Clinical Trials Program Med/Quantitative Sciences Unit
Haley is a Senior Biostatistician and Associate Director for the Clinical Trials Program within the Quantitative Sciences Unit. She collaborates with clinical researchers to design and implement studies and apply statistical methods. She has contributed to medicine and public health research on women’s health, cardiovascular and pulmonary students who are interested in learning more about study design and statistical methods.

Jennifer Howden, C.I.P. (certified IRB professional) Senior IRB / SCRO Manager
Jennifer has more than two decades of experience in human subject research, including Coordination and Management of Clinical Trials in studies of Major Depressive Disorder. She has been working with the Research Compliance Office since 2008, supporting the IRB and SCRO review process.

Peg Tsao, RN, CCRC – Associate Director, Clinical and Translational Research Operations, Spectrum
Peg has 20 years of experience in clinical research. She joined Stanford Health Care in 1994 as a critical care nurse. She transitioned to a Research Nurse position at the School of Medicine in 2002 in Interventional Cardiology. In 2006, she joined SPCTRM (now Spectrum, CTSA). Throughout her years with Spectrum, Peg has assisted numerous faculty and staff in navigating clinical research at Stanford. Currently Peg oversees the Clinical Research Operations Certification Program, the Trial Innovation Network, the Clinical Research Unit initiative, the KL2 Mentored Career Development Program and the Innovation Accelerator Pilot Program.