OCR CRA Support Core

The Office of Clinical Research (OCR) 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:

Jennifer McDonald, CRA II, CCRP

  • Degree: Bachelor of Science, Engineering, University of Washington
  • Education/Training: Society of Clinical Research Associates (SOCRA) certified, Graduate of the University of Washington’s Certificate Program in Clinical Trials
  • Experience at Children’s: Provided CRA support to the following pediatric research programs: Radiology, Neurosurgery, Hematology/Oncology, Pulmonary, Otolaryngology, Urology, Endocrinology, Neurology and Infectious Disease
  • Skills: Preparation of IRB materials, implementation of study procedures, obtaining consent from study participants, designing databases for recording study data, coordinating biological specimen processing activities, preparing and managing regulatory documentation, and monitoring study progress

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
  • Experience at Children’s: Provided CRA support to the following pediatric research departments: Emergency Department, Neurodevelopmental Medicine, Neurology, Neurosurgery, Pharmacy, and Rheumatology. 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: Good Clinical Practices
  • Experience at Children’s: Child Psychiatry, Dr. Jack McClellan and Dr. Bryan King, doing research related to Bipolar Disorder, Autism and Schizophrenia, Rheumatology, and Pulmonary
  • 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 OCR 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?
OCR 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 Jennifer McDonald to discuss your request and to help fill out the Support Core Request Form.