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.

All New SCI Staff
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).

All Clinical Research Coordinators and Data Managers
All new cancer clinical research staff and those who are based in departments and divisions who have not completed CCTO Orientation must complete the seven session Clinical Research Orientation.

ACTIVITY CONTACT
DAY 1
Stanford Orientation http://axess.stanford.edu
DAY 2
Office Orientation Employee’s supervisor
Cancer Institute/LPCH Tour Employee’s supervisor
Obtain Badge Employee's supervisor
EPIC Access and Training Employee's supervisor
Health Screening Employee's supervisor will provide a form prior to scheduling your screening.

For health related screening, please contact SU Occupational Health Center at (650) 725-5308; for any respiratory protection or safety training questions, contact SU Health and Safety Program at (650) 725-0448
Patient Privacy Training Once you have your email address, please send it to Barbara Lorimer, HR Manager. You will automatically be registered to take your Patient Privacy Training and an email invitation will be sent to you.
DAY 3
CITI Human Subjects
GCP Training - Group 7
http://www.citiprogram.org/
New employees should complete Group 7 in the first week.
Health and Safety Training Environmental Health & Safety
Healthstream Training You should receive an email invite for Healthstream training within two weeks after hire. If you do not receive an email please contact your supervisor..
DAY 4 -5
SCI Clinic orientation Employee's supervisor
Review SCI SOPs Standard Operating Procedures (SOPs)
SOP Review
DAY 7 -10
Spectrum Orientation You should receive an email with information about Spectrum Orientation within 7-10 days. If you have not received information by that time please contact your supervisor.

CLINICAL RESEARCH ORIENTATION
Registration for all sessions can be accessed through the STARS system. Search "CCTO" to view all seven sessions. Registration should be made in advance of 4 days prior to the session. The class will be cancelled if there is less than a minimum of three people. For questions on the orientation, contact Christy Baker.

All Clinical Research Staff must complete this seven session orientation. New staff must complete all sessions during their 6-month probationary period. All sessions are open to staff, fellows, and investigators involved in clinical research at SCI. Specific sessions may serve as a refresher for existing research staff, or may be appropriate for CRAs and others based upon responsibilities.

Please note that CRCs cannot work independently in clinic until session 2 and 7 are completed and both should be taken in the same week for continuity. Also, it is strongly recommended that new staff attend sessions 5 (Safety Documentation and Reporting) and 6 (Study Financial Management) after being on the job for at least one month.

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.
Dec 8 FC280 9:30-11:00AM
Jan 12 FC380 9:30-11:00AM
Jan 28 FC380 3:00-4:30PM
Feb 25 FC380 3:00-4:30PM
Mar 16 FC380 9:30-11:00AM
Mar 25 FC380 3:00-4:30PM
Apr 13 FC380 9:30-11:00AM
Apr 22 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
Session 3: Study Start Up and Regulatory Documentation
Regulatory Binders, Investigator-initiated trials and Sponsor-Investigator Research, SOPs for clinical research
Dec 10 FC380 3:00-4:30PM
Session 4: OnCore Training
» Please note that CITI/HIPAA training must be completed prior to OnCore access and training.
Basic Training (Required):
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
Comprehensive Training (Optional):
Dec 9 Basic Training Alway M206 1:30-4:00PM
Session 5: Safety Documentation and Reporting
Serious Adverse Event documentation, Unanticipated Problems and IRB reporting, Protocol Deviations, Outside Safety Reports
Dec 8 FC380 9:30-11:00AM
Session 6: Study Financial Management
Study budget development, Notice of Awards, Post Award
Session 7: Study Conduct Part II: Coordination of Study Operations
Audit Readiness, Documentation Practices, Case Report Forms, Record Retention, Patient Safety Goals
Nov 21 FC180 10:00AM-3:00PM

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.

Stanford Medicine Resources:

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