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Clinical Research Staff Support Core

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The Clinical Research Staff Support Core (CRSSC) is a team of experienced clinical research staff available to collaborate with investigators and their research teams in all phases of clinical research. The CRSSC provides services that include assisting with the organization, implementation and completion of clinical research trials. Staff in the CRSSC have expertise in a wide range of areas and are well-versed in federal regulations, good clinical practice (GCP) and Seattle Children’s institutional requirements and policies.

Services

The following are examples of services are offered to investigators upon request:

Study start-up

  • Prepare and submit:
    • Institutional Review Board (IRB)/ ITHS application
    • Protocols
    • Consent forms
    • Approach letters/recruitment materials
  • Coordinate and facilitate site-initiation visits
  • Coordinate hospital service set-up
  • Complete and gather regulatory documents
  • Design and build databases

Study coordination

  • Recruit, screen and assist with eligibility determination of study participants
  • Conduct consent conferences and obtain informed consent
  • Schedule research procedures, facilitate research visits and manage data collection and entry
  • Coordinate shipment of research specimens
  • Nurse activities (e.g., blood draw, IV placement, specimen collection, participant education, adverse event assessment and reporting and pain scores)
  • Prepare and submit IRB and SRC amendments and renewals
  • Coordinate Data and Safety Monitoring Board (DSMB) meetings
  • Assist clinical staff with monitoring and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Administer surveys/questionnaires
  • Data entry and query resolution

Study closeout

  • Assist with study closeout visits
  • Data preparation for statistical analysis
  • Verify that studies meet IRB standards for study closure
  • Data query resolution
  • Manage research files and data storage

Location, Contact and Hours of Operation

Email the CRSSC.

The Clinical Research Staff Support Core is located in the Clinical Research Center (level 8, Ocean zone) on the main hospital campus and at Seattle Children’s Research Institute's Jack R. MacDonald Building, 1900 Ninth Ave. Core staff are available Monday through Friday, during regular business hours. Extended and weekend hours may be available upon request approval.

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