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
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. Questions? Contact: hssc-support@lists.stanford.edu
DAY 4 -5
SCI Clinic orientation Cancer Care Program Manager
Review SCI SOPs Standard Operating Procedures (SOPs)
SOP Review

CLINICAL RESEARCH ORIENTATION
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, thought 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. Advance registration is not required, except for OnCore Training. 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.
Mar 31 FC380 9:30-11:00AM
Apr 28 FC380 9:30-11:00AM
May 21 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
Apr 30 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
Apr 16 FC380 3:00-4:30PM
May 5 FC380 9:30-11:00AM
Session 4: OnCore Training
Basic 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
Optional Advanced Training:
1) Reporting with OnCore - Reports, Protocol Search and Subject Search
2) Use of OnCore for investigator-initiated studies (Stanford only or Multi-site)
3) Open Session- continuation of advanced topics or topic of your choosing.
Apr 14 Basic Training Alway M206 1:00-3:30PM
May 19 Basic Training Alway M206 2:00-4:00PM
» 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
Apr 23 FC380 3:00-4:30PM
May 7 FC380 3:00-4:30PM
Session 6: Study Financial Management
Study budget development, Notice of Awards, Post Award
Apr 9 FC380 3:00-4:30PM
May 12 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
Apr 2 FC380 3:00-4:30PM
May 14 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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