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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, site management, and adherence to regulatory guidelines, with a strong focus on data integrity and protocol compliance. Proficient in utilizing CTMS, eTMF, and EDC systems while maintaining effective communication and organizational skills.
Highest-signal resume keywords
Clinical Research ExperienceSite ManagementRemote MonitoringKnowledge of Regulatory GuidelinesCTMS Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial MonitoringData CollectionProtocol AdherenceSite Monitoring ReportsECRF ResolutionSOP ReviewsInvestigational Product ReconciliationPatient Information ReviewRegulatory SubmissionsStudy Feasibility Assessments
Soft Skills
Attention to DetailOrganizational SkillsEffective CommunicationCritical ThinkingResolution Skills
Tools & Technologies
CTMSETMFEDCMicrosoft Office
Industry Keywords
Clinical TrialsObservational StudiesEuropean Monitoring ActivitiesInformed Consent ReviewEthics Committee Submissions
About the role
Key responsibilities & impact- Monitor clinical trials and observational studies for protocol adherence, site activities, data collection, and data integrity
- Perform remote and on-site monitoring according to project timelines
- Schedule travel and submit expense reports according to UBC policies
- Attend project team, department, and manager meetings
- Complete site monitoring reports and follow-up letters with minimal corrections
- Follow up on site issues and action items within required timelines
- Enter site visits, monitoring reports, follow-up dates, and site contacts into the CTMS
- Monitor EDC data entry and assist sites with eCRF resolution
- Review Investigator Site Files and reconcile Investigational Product
- Maintain regular contact with assigned sites
- Complete SOP reviews, training assessments, and required documentation
- Perform European monitoring activities, including patient information and informed consent review, regulatory submissions, CTIS tracking, ethics committee submissions, contract negotiations, payment confirmation, eTMF maintenance, essential document tracking, and study feasibility assessments
- Perform Site Management and Monitoring activities according to project plans and timelines
- Assist with other duties as assigned
Requirements
What you’ll need- Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience
- Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring
- Preferably at least 6 months’ on-site monitoring experience
- Knowledge of medical terminology and regulatory guidelines, including local legislation
- Strong attention to detail and excellent organizational skills
- Effective communication, critical thinking, and resolution skills
- Ability to deliver accurate work and adhere to deadlines in a fast-paced environment
- Good written and verbal communication skills in English and local language, as applicable
- Experience with CTMS, eTMF, EDC, and Microsoft Office applications
- Willingness/ability to travel up to 50% in the European region
Benefits
Comp & perks- Equal opportunity employer committed to a diverse, equitable and inclusive culture
- Inclusive workplace that fosters creativity
- Career growth and meaningful impact opportunities