Senior Clinical Research Associate

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

📋 Description

• Oversees clinical trials and observational studies, ensuring adherence to protocols, managing site activities, and supervising data collection and integrity.

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

• Provides mentorship and training to junior-level CRAs.

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

• Manages travel scheduling following project-specific and UBC travel policies.

• Submits expense reports in accordance with UBC requirements.

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

• Prepares site monitoring reports and letters according to UBC and/or sponsor SOPs, requiring minimal revisions.

• Ensures that site issues and action items are followed up in accordance with UBC/sponsor timelines.

• Inputs site visits, site 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) resolution.

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

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

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

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

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

• Supports the PM and/or Lead CRA with additional tasks as required.

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

• Performs other assigned duties that may correspond with other departments at UBC.

⛳️ Requirements

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

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

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

• Strong critical thinking and problem-solving skills.

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

• Preferred experience in clinical trials and observational studies.

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

• Demonstrated ability to deliver precise work and meet deadlines in a fast-paced setting.

🏝️ 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) and Flexible Spending Account (FSA).

• Telemedicine (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance options.

• Employee discount programs.