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About the role
Key responsibilities & impact- 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.
Requirements
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Site SelectionSite InitiationSite ManagementData CollectionMedical TerminologyCritical ThinkingResolution Skills
Soft Skills
MentoringTrainingTeam Collaboration