Sr Clinical Research Associate - Oncology

CHEManager International · United States · Yesterday

RemoteRemoteAnalystFull-time

Maintains compliance with clinical trial protocols, manages site activities, ensures data integrity, and mentors junior CRAs.

Performs remote and on-site monitoring in accordance with project timelines
Schedules travel in accordance with project and UBC policies
Submits expense reports within UBC requirements
Attends project team meetings and department meetings
Completes site monitoring reports and letters according to SOPs
Follows up on site issues and action items
Enters monitoring visit details and site contacts into CTMS
Monitors EDC data entry and assists with eCRF resolution
Reviews investigator site files and performs product reconciliation
Maintains regular contact with assigned sites
Completes SOP reviews, training assessments, and documentation within requested timelines
Mentors and trains junior CRAs
Aids in preparing and delivering presentations for UBC training sessions
Assists with other tasks as needed
Travels up to 80% in the North American region
Carries out site management and monitoring activities according to project plans
Assists with other duties as assigned

Bachelor's degree in Life Science preferred or equivalent years of industry 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
Strong written and verbal communication skills in English and local language (as applicable)
Experience working in clinical trials and observational studies
Familiarity with CTMS, eTMF, EDC, and Microsoft Office applications
Proven ability to deliver accurate work and meet deadlines

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