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 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 - Click on "Payment Authorization Form" in right column
Arrange Spectrum Orientation Spectrum
HIPAA Training http://hipaa.stanford.edu/
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 http://www.healthstream.com/hlc/stanford
Wait for login instructions before proceeding.
DAY 4 -5
SCI Clinic orientation Cancer Care Program Manager
Review SCI SOPs Standard Operating Procedures (SOPs)
SOP Review

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. Session can be taken in any order, though ideally new staff will start with session one, and attend sessions in order. It is strongly recommended that new staff attend session 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.
Aug 4 FC380 9:30-11:00AM
Aug 13 FC380 3:00-4:30PM
Sep 17 FC380 3:00-4:30PM
Sep 29 FC380 9:30-11:00AM
Oct 15 FC380 3:00-4:30PM
Nov 3 FC380 9:30-11:00AM
Session 2: Study Conduct Part I: Navigating Interdepartmental Services
Role of Research Coordinator, Working with CTRU, Pharmacy, ITA, and Lab, Coordinator Resources
Aug 25 FC380 9:30-11:00AM
Sep 3 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
Aug 11 FC380 9:30-11:00AM
Aug 20 FC380 3:00-4:30PM
Sep 8 FC380 9:30-11:00AM
Oct 8 FC380 3:00-4:30PM
Nov 10 FC380 9:30-11:00AM
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):
Aug 21 Basic Training - CANCELLED due to low attendance Alway M206 1:30PM-4:00PM
Sep 23 Basic Training Alway M206 1:30-4:00PM
Oct 15 Basic Training Alway M206 1:30-4:00PM
Nov 4 Comprehensive Training FC180 10:00AM-12:00PM
Nov 18 Basic Training Alway M206 1:30-4:00PM
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
Sep 22 FC380 9:30-11:00AM
Oct 1 FC380 3:00-4:30PM
Oct 20 FC380 9:30-11:00AM
Nov 12 FC380 3:00-4:30PM
Dec 8 FC380 9:30-11:00AM
Session 6: Study Financial Management
Study budget development, Notice of Awards, Post Award
Aug 27 FC380 3:00-4:30PM
Sep 24 FC380 3:00-4:30PM
Oct 6 FC380 9:30-11:00AM
Oct 29 FC380 3:00-4:30PM
Nov 17 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
Aug 6 FC380 3:00-4:30PM
Sep 10 FC380 3:00-4:30PM

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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