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UBC

Patients First. Powered by Evidence.

Senior Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 1,001-5,000Since 2003H1B No SponsorCompany SiteLinkedIn

Location

North America

Posted

2 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Senior Clinical Research Associate

UBC

• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Mentors and trains junior level CRAs. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs. • Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training. • Assists PM and/or Lead CRA with additional tasks as needed. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines. • Assists with other duties as assigned, which may align with other departments at UBC.

Job Requirements

  • Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
  • Minimum of 36 months on-site monitoring experience including site selection, initiation, management, and monitoring activities
  • Comprehensive knowledge of medical terminology and regulatory guidelines
  • Excellent critical thinking and resolution skills
  • Excellent written and verbal communication skills in English and local language (as applicable)
  • Experience working in clinical trials and observational studies preferred
  • Experience and familiarity with CTMS, eTMF, EDC, Microsoft Office applications
  • Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment

Benefits

  • 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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