Click HERE to Register!
Presenter: Kristin Anderberg, RN, BSN
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 SCCR’s Quality and Compliance Manager, Kristin Anderberg, RN, BSN, to present you with quality incident reporting, and how it does differ from CAPA.
At the conclusion of this class, you will be able to:
- Understand Quality Incidents
- Recognize why quality incident reporting is important
- Identify how quality incident differ from CAPA
- Apply your learning to research
Attendance is open to all research staff
About the Instructor:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
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.
Click HERE to Register!
Presenters: Kristin Anderberg, RN, BSN & Doran Triggs, BS
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 SCCR’s Quality and Compliance Manager, Kristin Anderberg, RN, BSN, and her team member Doran Triggs, BS, to provide you an overview of the TMF and importance of maintaining a TMF.
At the conclusion of this class, you will be able to:
- Understand the definition of TMF and ISF
- Recognize the requirements
- Learn how to manage the TMF
- Identify recommended contents for TMF
- Understand Inspection Readiness
- Outline common errors
Attendance is open to all research staff
About the Instructors:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
Doran Triggs, BS, is a Clinical Research Coordinator II, within SCCR’s Quality and Compliance team. Doran has been in the clinical research field for over 4 years. She first joined SCCR in 2018 as a CRC working on Vascular Surgery and Women’s Heart Health trials. Within her 4 years Doran focused her training on regulatory compliance and study data monitoring. Since 2021 she has transitioned to a role on SCCR’s Quality and Compliance team where she provides support to study teams within SCCR. Most recently she helped develop and manage SCCR’s monitoring program as well as monitor multiple trials within SCCR and other departments across the SOM.
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.
Click HERE to Register!
Presenters: Leonard Basobas, MS, and Kiera Davis, MS, RN, BSN
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 Instructors:
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.
Click HERE to Register!
Presenters: Kristin Anderberg, RN, BSN
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 SCCR’s Senior Quality and Compliance Manager, Kristin Anderberg, RN, BSN, to provide you with the common findings from FDA inspections and site audits.
At the conclusion of this class, you will be able to:
- Define FDA Inspection/BIMO
- Understand most common BIMO findings
- Outline FDA references
- Define audit
- Identify most common findings
- Recognize pitfalls and how to avoid them
Attendance is open to all research staff
About the Instructors:
Kristin Anderberg, RN, BSN received her BSN from Emory University in Atlanta. Following graduation she worked in the pediatric cardiac ICU. She has over 30 years of research experience working for AROs and industry. Her knowledge extends to clinical trial management for global studies, GCP, compliance audits, regulatory agency inspections, clinical events classification, quality management of clinical trials, policy and procedure development. She currently works at SCCR as Quality and Compliance Manager, and her passion in research is quality, clinical events classification, and endpoint adjudication.
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.