Senior Clinical Research Associate

This is a fully remote position, open to applicants in North America.

📋 Description

• Oversees clinical trials and observational studies, ensuring compliance with protocols, managing site activities, and maintaining data collection integrity.

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

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

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

• Manages travel arrangements based on project-specific needs and UBC travel policies.

• Submits expense reports adhering to UBC requirements.

• Participates in project team, departmental meetings, and individual meetings with management.

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

• Ensures timely follow-up on site issues and action items in accordance with UBC/sponsor timelines.

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

• Monitors data entry within Electronic Data Capture (EDC) systems, if applicable, and assists sites with electronic Case Report Form (eCRF) resolutions.

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

• Maintains consistent communication with assigned sites as required by study protocols.

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

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

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

• Assists the PM and/or Lead CRA with additional responsibilities as needed.

• Executes Site Management and Monitoring activities as per project-specific plans and timelines.

• Takes on other duties as assigned, which may involve collaboration with other departments at UBC.

⛳️ Requirements

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

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

• In-depth knowledge of medical terminology and regulatory guidelines.

• Strong critical thinking and problem-solving abilities.

• Exceptional written and verbal communication skills in English and local language (if applicable).

• Experience in clinical trials and observational studies is preferred.

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

• Demonstrated ability to produce highly accurate work and meet deadlines in a fast-paced environment.

🏝️ Benefits

• Remote work opportunities.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching*

• Tuition reimbursement programs.

• Flexible work 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 programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Discount programs.