Senior Clinical Research Associate – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversees clinical trials and observational studies to ensure compliance with protocols, manage site operations, and maintain data integrity.

• Verifies that study sites are executing the study(ies) and reporting data in accordance with applicable regulations, guidelines, and sponsor requirements.

• Provides mentorship and training to junior-level Clinical Research Associates (CRAs).

• Conducts both remote and on-site monitoring in line with specific project timelines.

• Arranges travel in accordance with project specifications and UBC travel policies.

• Files expense reports in compliance with UBC standards.

• Participates in project team meetings, department meetings, and one-on-one sessions with the manager.

• Prepares site monitoring reports and correspondence following UBC and/or sponsor Standard Operating Procedures (SOPs) with minimal revisions needed.

• Ensures timely resolution of site issues and action items according to UBC/sponsor timelines.

• Records site visits, monitoring reports, follow-up letter dispatch dates, and site contacts in UBC’s Clinical Trial Management System (CTMS).

• Monitors data entry within Electronic Data Capture (EDC) systems, if applicable, and aids sites in resolving electronic Case Report Form (eCRF) issues.

• Reviews the Investigator Site File and conducts Investigational Product reconciliation.

• Maintains consistent communication with assigned sites as per study requirements.

• Completes all SOP reviews, training assessments, and documentation within the specified timelines.

• Supports the Project Manager (PM) and management team by mentoring, training, and evaluating junior CRAs.

• Aids in the preparation and/or presentation of materials for UBC CRA training, departmental training, and/or sponsor-specific training.

• Executes Site Management and Monitoring activities according to project-specific plans and timelines.

• Takes on additional tasks as assigned, which may align with other departments within UBC.

⛳️ Requirements

• Bachelor’s degree in Life Science preferred or equivalent experience in industry and clinical research.

• At least 36 months of on-site monitoring experience, including site selection, initiation, management, and monitoring activities.

• Thorough understanding of medical terminology and regulatory guidelines.

• Strong critical thinking and problem-solving abilities.

• Excellent written and verbal communication skills in English and the local language (where applicable).

• Preferred experience in clinical trials and observational studies.

• Familiarity with CTMS, eTMF, EDC, and Microsoft Office applications.

• Demonstrated ability to produce highly accurate work while meeting deadlines in a fast-paced setting.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement and promotion.

• 401K plan with company matching*

• Tuition reimbursement programs.

• Flexible working environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Comprehensive medical, dental, and vision coverage.

• Health Savings Account (HSA) / Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness program.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance options.

• Discount programs.