Cancer Institute A national cancer institute
designated cancer center
Cancer Clinical Trials Office

New Employee Orientation

Clinical research can be challenging and thorough training is necessary for efficient management of clinical research according to the appropriate local and federal regulations. New employees at SCI must undergo a 4-5 day orientation before starting any research responsibilities. During this mandatory orientation period staff will be expected to complete on-line trainings including CITI GCP Training, attend or schedule attendance at CCTO and clinic orientation meetings, and review Standard Operating Procedures (SOPs).

Clinical Research Coordinators: see additional orientation requirements below.

ACTIVITY CONTACT
DAY 1
Stanford Orientation http://axess.stanford.edu
DAY 2
Office Orientation Employee’s Manager
Cancer Institute/LPCH Tour Employee’s Manager
Obtain Badge SHC security department
Sign up for Epic Access and Training New Epic Users
Health Screening Spectrum
Arrange Spectrum Orientation Spectrum
HIPAA Training http://hipaa.stanford.edu/
DAY 3
CITI Human Subjects
GCP Training
http://www.citiprogram.org/
Health and Safety Training Environmental Health & Safety
Healthstream Training http://healthstream.com/hlc/susom
Use SU employee ID for username and password.
DAY 4 -5
SCI Clinic orientation Disease Management Group Manager
Review SCI SOPs Standard Operating Procedures (SOPs)
SOP Review

COORDINATOR ORIENTATION
SCI Clinical Research Orientation consists of eight sessions designed for SCI Clinical Research Coordinators. All new Clinical Research Coordinators will need to complete seven CCTO Orientation Sessions during their 6-month probationary period. All sessions are open to staff, fellows, and investigators involved in clinical research at the Stanford Cancer Institute. Specific sessions may serve as a refresher for existing research staff, or may be appropriate for data managers, CRAs, and others based upon responsibilities. Sessions can be taken in any order, though ideally new staff will start with session one, and attend sessions in order. Advance registration is not required, except for OnCore Training (see Session 4 for details). For questions on the Orientation, contact CCTO-Office@stanford.edu
Session 1: Overview of Clinical Research at the Stanford Cancer Institute
Introduction to the Stanford Cancer institute and Cancer Clinical Trials Office, orientation requirements, study activation process, relevant websites and resources. Introduction to C-I-CARE, Patient Safety Goals, and JCAHO, including a facilities tour.
Jun 3 FC380 9:30-11:00AM
Jun 19 FC380 3:00-4:30PM
Jul 22 FC380 9:30-11:00AM
Aug 28 FC380 3:00-4:30PM
Session 2: Study Conduct Part I: Navigating Interdepartmental Services
Role of Research Coordinator, Working with CTRU, Pharmacy, ITA, and Lab, Coordinator Resources
Jun 10 FC380 9:30-11:00AM
Jun 26 FC380 3:00-4:30PM
Jul 29 FC380 9:30-11:00AM
Sep 11 FC380 3:00-4:30PM
Session 3: Study Start Up and Regulatory Documentation
Regulatory Binders, Investigator-initiated trials and Sponsor-Investigator Research, SOPs for clinical research
Jun 17 FC380 9:30-11:00AM
Jul 24 FC380 3:00-4:30PM
Aug 5 FC380 9:30-11:00AM
Sep 18 FC380 3:00-4:30PM
Session 4: OnCore Training
General overview of and introduction to OnCore functionality, review of OnCore data entry requirements for research studies and hands-on practice plus OnCore homepage setup for your favorite protocols, participants, reports, searches and more
Jun 13 Basic Training Alway M206 9:00-10:30AM
Jul 17 Basic Training Alway M206 1:00-2:30PM
Aug 13 Basic Training Alway M206 10:30AM-12:00PM
» To register for OnCore Training, email CCTO-OnCore@stanford.edu. Please note that CITI/HIPAA training must be completed prior to OnCore access and training.
Session 5: Safety Documentation and Reporting
Serious Adverse Event documentation, Unanticipated Problems and IRB reporting, Protocol Deviations, Outside Safety Reports
Jun 24 FC380 9:30-11:00AM
Jul 31 FC380 3:00-4:30PM
Aug 12 FC380 9:30-11:00AM
Sep 25 FC380 3:00-4:30PM
Session 6: Study Financial Management
Study budget development, Notice of Awards, Post Award
Jun 5 FC380 3:00-4:30PM
Jul 10 FC380 3:00-4:30PM
Aug 7 FC380 3:00-4:30PM
Sep 16 FC380 9:30-11:00AM
Session 7: Study Conduct Part II: Coordination of Study Operations
Audit Readiness, Documentation Practices, Case Report Forms, Record Retention, Patient Safety Goals
Jun 12 FC380 3:00-4:30PM
Jul 15 FC380 9:30-11:00AM
Aug 14 FC380 3:00-4:30PM
Sep 23 FC380 9:30-11:00AM

Formal training courses for clinical research coordinators are offered by professional organizations and are highly encouraged for all research staff. The Association of Clinical Research Professionals (ACRP) and the Society for Clinical Research Associates (SoCRA) offer certification programs that are rigorous and add to the clinical research. The Stanford Association of Research Professionals (SARP) is a diverse group of individuals working together to provide a forum for communication, education and networking with the goal of achieving excellence in clinical research.

Stanford Medicine Resources:

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