Clinical Research Quality & Compliance Specialist I-II (Monitor)

Employment Type
Regular Full-Time
Requisition number
1774
Department
Research Integrity & Safety Department
Location : City
Seattle

Overview

Benaroya Research Institute at Virginia Mason (BRI) is an independent non-profit organization within Virginia Mason Franciscan Health.  We collaborate with clinicians to accelerate the path from innovative lab discoveries to life-changing patient care. 

This position is designed to provide monitoring services (approximately 65-75% of the time) for clinical research trials performed primarily at Virginia Mason Franciscan Health with a secondary responsibility to assist with staff training and education, document control, CAPA creation assistance and follow-up, and other study staff support as needed.

Monitoring work typically focuses on moderate to high-risk studies, with special emphasis on Sponsor-Physician research and oncology studies. As an internal monitor, this position will work with the research staff to assure fundamental clinical research knowledge, mistake-proofing, and long-term success.

Responsibilities

  • Internal Risk Based Monitoring to include:
    • Reviewing and comparison of selected subject source documentation to the IRB-approved protocol for adherence in study procedure completion as well as Test Article administration
    • Correct Informed Consent documentation
    • Eligibility criteria verification
    • Reviewing selected subject medical record to confirm complete Adverse Event capture and safety procedure completion
    • Ensure adherence to applicable Federal Regulations as well as Institutional Policies and Procedures
    • Review financial files for proper attribution of standard or research charges
    • Creation and distribution of written report of findings, to include follow up as needed
    • Work with research staff to identify the root cause(s) of problems or barriers and assist in the creation of a corrective and preventive action plan(s)
  • Assist in review and preparation of study documents for outside audits (e.g., Sponsor, CRO, IRB, and/or FDA Inspections)
  • Internal review of the program-wide central document repository (e.g., CV’s, license, laboratory documentation, equipment calibration, etc.)
  • Assist with the creation or alteration of subject source document templates
  • Regulatory documentation audits, with emphasis on timely IRB submission and approval, Delegation of Authority log and study staff training documentation, and Test Article Accountability Record accuracy
  • Provide feedback on Investigator Initiated trials during the start-up process to assure compliance concerns have been addressed prior to study activity
  • Document Control which includes assistance with writing and reviewing policies, procedures, and/or instructions
  • Various software will be utilized (e.g., Clinical Conductor, Cerner, GE, Box.com, Sharepoint, REDCap, etc.)
  • Additional projects assigned as needed
  • Position can work remotely up to 40% 

Incumbents should have good working knowledge of the IRB process, good problem-solving abilities, be detail-oriented, personable, and understand a research protocol and documentation requirements. Incumbents must be diplomatic with a positive, customer service-oriented attitude in order to work effectively with study staff to ensure clinical research objectives are achieved in an efficient, compliant and effective manner. Requires critical thinking abilities and must function independently.

Requirements

  • Bachelor’s degree and ACRP/SOCRA certification strongly preferred
  • One year clinical research monitoring preferred or two years as a study coordinator, with oncology research experience preferred
  • Working knowledge of Good Clinical Practices, including 21 CFR Part 50, 54, 56, 312, 314, 812, 814 and ICH Guidelines is expected
  • May substitute a Master’s degree in Clinical Research or other related field, MD for one year of study coordinator experience

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, citizenship, disability or protected veteran status.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed