Center for Clinical and Translational Research Staff Support Core

The Center for Clinical and Translational Research (CCTR) coordinates a core of clinical research staff that are available to investigators to support and collaborate with their research teams with the organization, implementation and completion of clinical research trials studies.

Core resources are dependent on staff availability.

Services

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

Study Preparation

Prepare consent forms, approach letters, and recruitment materials
Prepare and submit Institutional Review Board (IRB) applications
Prepare and submit SAC applications
Create regulatory binders
Assist in the completion of regulatory forms and gathering of regulatory documents (SFIs, CVs, licenses, laboratory certifications (CAP, CLIA), FDA 1572
Organize study materials
Coordinate and facilitate site initiation visits
Hospital service set-up (RSPL, laboratory, radiology, heart center)
Design simple databases (Excel and Access)

Study Implementation

Prepare and submit IRB amendments and renewals
Prepare and submit SAC amendments and annual reports
Determine patient eligibility for studies along with the investigator/research team
Schedule subject visits
Accompany families and patients during study visits
Explain study basics to patients and families
Consent patients/families for minimal risk studies (registry studies, blood collection studies, etc)
Coordinate research activities with hospital services
Process research biological specimens
Collect case report form (CRF) data and complete case report forms (CRFs)
Input data into databases
Review medical records and decision support reports for expedited review studies
Assist with study monitor visits
Coordinate Data and Safety Monitoring Board (DSMB) meetings
Assist clinical staff in monitoring and reporting Adverse and Serious adverse events

Study Close-out

Coordinate monitor study closeout visits
Verify that study meets IRB standards for study closure
IRB and SAC notification of study closure
Data Resolution
Work with biostatisticians to validate study data
Facilitate research file and data storage

Support Core Personnel

Below are various skills from our current support core:

Interview research participants
Collect medical record data
Design and manage research databases
Experienced in IRB and SAC submission
Experienced with multi-center, investigator initiated, and registry studies
Experienced with NIH and corporately funded studies
Experienced in working with Contract linical Research Organizations (CROs)
Advanced knowledge in medical terminology
Knowledge of NIH, FDA, and HIPAA research study regulations
Experienced in Good Laboratory Practice (GLP)
Coordinate research care activities with hospital services
Coordinate biological specimen processing
Experience in working with investigators from various pediatric research departments such as Anesthesiology, Emergency, Infectious Disease, Neurodevelopmental Medicine, Nephrology, Neurology, Neurosurgery, Pharmacy, Radiology, and Rheumatology. Experience in working with the University of Washington Medical Center and General Clinical Research Center (GCRC). Additional CRA support provided to the Harborview Injury Prevention and Research Center.

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

Janna Stults, CRA II

Degree: Bachelor of Arts, Biology, minors in Psychology and Chemistry, Western Washington University
Education/Training: Human Subjects Protection Training, Fred Hutchison Cancer Research Center; Children's Hospital Consent, Assent and Parental Permission Mentoring Program (CAPP); Good Clinical Practice, University of Washington; Biological Substances Category B Transport and Shipping; Fundamentals of Project Management, Children's Hospital Research Institute; State of Washington Health Care Assistant License Category A
Experience at Children's: Experience in managing multiple clinical research studies at Children's Hospital. Experience with multi-center, investigator initiated, and registry studies. Experience with NIH and corporately funded studies. Experienced in working with Clinical Research Organizations (CROs). Experienced in IRB submission. Advanced in medical terminology. Knowledge of NIH, FDA, and HIPAA research study regulations; experience in Good Laboratory Practice (GLP). Credentialed at the University of Washington Medical Center
Skills: Implementation of study procedures, recruiting eligible study participants, scheduling and facilitating study subject visits, obtaining consent from study participants, interviewing research participants, medical record data collection, data entry, preparation and submission of IRB applications, amendments and renewals, preparation of consent forms, approach letters, and recruitment materials, coordination with hospital services such as heart center, radiology, and laboratory, coordinating biological specimen processing activities, outstanding interpersonal and communication skills; superior accuracy in research documentation. Ability to work collaboratively in a team environment. Self-starter, organized, detail-oriented, creative, innovative, energetic.

How to Apply for Services

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

Frequently Asked Questions about the CRA Support Core

What are the advantages to using the Support Core?
The Support Staff:

Are already trained to Children's and Research
Are familiar with: institutional policies; working with hospital service areas; the Pediatric Clinical Research Center (PCRC)
Only charge for study specific activities; no charge for shuttle time etc.

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 Center Business Manager to provide a cost estimate.

How are core resources assigned?
Core resources are dependent on staff availability and assignments are determined by the CCTR Clinical Operations Director.

How will I know if my request for Support Core services can be met?
CCTR 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.