ORCE CRA Support Core

The Office of Research Compliance and Education coordinates a core of clinical research associates that are available to investigators to support their research teams with the organization, implementation and completion of clinical research trials.

The CRA Support Core provides temporary, part-time coverage. Core resources are dependent on staff availability.

Services

The following are examples of services available from the support core:

  • Preparation and submission of Institutional Review Board (IRB) applications, amendments and renewals
  • Preparation of consent forms, approach letters, and recruitment materials
  • Regulatory binder creation and initial organization
  • Simple database design (Excel and Access)
  • Data entry
  • Scheduling and facilitating study subject visits
  • Medical records review for expedited review studies
  • Assistance with study monitor visits

CRA Support Core Personnel

Below are highlights of qualifications from our current support core:

Shawn Hagland, CRA I

  • Degree: Bachelor of Science, Biology, University of Portland
  • Education/Training: Completed the Children's Hospital Consent, Assent and Parental Permission Mentoring Program (CAPP), New Horizons Microsoft Access 2003 Level I certified, CITI Good Clinical Practice and ICH Curriculum, University of Washington's Certificate Program in Clinical Trials
  • Experience at Children's: Provided CRA support to the following pediatric research departments: Emergency Department, Infectious Disease, Neurodevelopmental Medicine, Neurology, Neurosurgery, Pharmacy, and Rheumatolgy. Additional CRA support provided to the Harborview Injury Prevention and Research Center.
  • Skills: Recruiting eligible study participants, obtaining consent from study participants, interviewing research participants, medical record data collection, designing research databases, managing research databases, and preparing IRB study materials.

Tiffany Glant, CRA I

  • Degree: Bachelor of Science, Psychology, University of Arizona
  • Education/Training: CITI Good Clinical Practices, New Horizons Microsoft Access 2003 Level I certified, attended the Children's Hospital Assent and Parental Permission Mentoring Program (CAPP).
  • Experience at Children's: Provided CRA support to the following research departments: Pulmonary, Rheumatology, and Psychiatry.
  • Skills: Advertising and recruiting eligible study participants, scheduling, interviewing and recording research participants, preparing IRB study materials, data entry and verification, and the administration of psychometric assessments.

How to Apply for Services

To apply, please complete the ORCE CRA Support Core Request Form (DOC 45KB).

Frequently Asked Questions about the CRA Support Core

Are there fees for services?
Yes. CRA Support Core staff will charge their time to your research account (Lawson activity number). As part of the application process, we will review the Full Time Equivalency (FTE) requirements associated with your request and work with you and your Sponsored Projects Officer to provide a cost estimate.

How are core resources assigned?
Core resources are dependent on staff availability and assignments are determined by the Director, Office of Clinical Research.

How will I know if my request for CRA Support Core services can be met?
ORCE staff will contact you within two weeks of the date your application was submitted to inform you if your request can or cannot be met.

What if I need a service that is not on the list?
Please contact Pam Joy to discuss your request and to help fill out the Support Core Request Form.