Clinical Research Associate

4 days ago


Remote, Oregon, United States United BioSource Full time
Job Title: Sr. Clinical Research Associate

United BioSource is seeking a highly skilled and experienced Sr. Clinical Research Associate to join our team. As a Sr. Clinical Research Associate, you will be responsible for monitoring clinical trials in accordance with International Conference on Harmonisation, Good Clinical Practice guidelines, Code of Federal Regulations, and UBC SOPs.

Key Responsibilities:
  • Monitor clinical trials in accordance with project-specific protocols and timelines.
  • Conduct site visits and complete site monitoring reports, confirmation/follow-up letters, and site monitoring reports in accordance with UBC and/or sponsor SOPs.
  • Ensure follow-up of site issues and action items per UBC/sponsor timelines.
  • Enter site visits, confirmation/follow-up letters, and site monitoring reports into UBC's Clinical Trial Management System.
  • Monitor within Electronic Data Capture data entry, if applicable, and assist sites with Case Report Form resolution.
  • Complete Regulatory Binder and Investigational Product reconciliation.
  • Maintain regular contact with assigned sites per study requirements.
  • Submit expense reports within UBC timelines and follow UBC Travel Guidelines.
  • Complete SOP review and documentation within requested timelines.
  • Complete sponsor-specific training and documentation within requested timelines.
  • Assist PM and management team by being an Assess Instruct and Mentor leader.
Requirements:
  • Bachelor's degree - Life Science preferred or equivalent years of industry and monitoring experience.
  • Minimum of 24 months active monitoring experience.
  • Thorough knowledge of medical terminology.
  • Good written and verbal communication skills.
  • Consistently meets or exceeds metrics for quality trip reports and letters.
  • Consistently meets or exceeds metrics for completion of UBC and/or sponsor training with appropriate documentation.
  • Ability to perform tasks in UBC's Clinical Trial Management System, Electronic Data Capture System, Outlook, and client-specific systems (if applicable).
  • Thorough knowledge of International Conference on Harmonisation, Good Clinical Practice guidelines, Code of Federal Regulations, and UBC SOPs.
  • Up to 80% travel.
Benefits:

At United BioSource, we offer a comprehensive benefits package to ensure that you have everything you need to thrive personally and professionally. Some of the exciting perks we offer include:

  • Remote opportunities.
  • Competitive salaries.
  • Growth opportunities for promotion.
  • 401K with company match.
  • Tuition reimbursement.
  • Flexible work environment.
  • Discretionary PTO (Paid Time Off).
  • Paid Holidays.
  • Employee assistance programs.
  • Medical, Dental, and vision coverage.
  • HSA/FSA.
  • Telemedicine (Virtual doctor appointments).
  • Wellness program.
  • Adoption assistance.
  • Short-term disability.
  • Long-term disability.
  • Life insurance.
  • Discount programs.

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