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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in monitoring clinical trials and observational studies, ensuring protocol adherence, data integrity, and compliance with regulatory guidelines. Proficient in mentoring junior CRAs and managing site activities while delivering accurate work within project timelines.
Highest-signal resume keywords
On-Site Monitoring ExperienceClinical Trial Management System (CTMS)Electronic Data Capture (EDC)Regulatory Guidelines KnowledgeExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site SelectionSite InitiationSite ManagementData CollectionMedical TerminologyCritical ThinkingResolution Skills
Soft Skills
MentoringTrainingTeam Collaboration
Tools & Technologies
CTMSETMFEDCMicrosoft Office
Industry Keywords
Clinical TrialsObservational StudiesProtocol AdherenceSOP ReviewInvestigational Product Reconciliation
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