Senior Clinical Research Associate – FSP

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

📋 Description

• Oversee relationships with investigator sites and manage clinical trial site activities from activation to database lock and close-out.

• Ensure compliance of clinical trials with the Study Monitoring Plan, relevant laws, Good Clinical Practices (GCP), and Sponsor standards.

• Act as the main point of contact for assigned investigator sites while coordinating with the Site Care Partner and study team.

• Perform onsite and remote/electronic monitoring during site initiation, routine monitoring, and site closure.

• Provide coaching and training for site personnel, including protocol training and recruitment assistance.

• Monitor adverse events and serious adverse events, collaborating with the Drug Safety Unit.

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply management, and study progress metrics.

• Identify and resolve site-related issues, develop corrective and preventive actions, and address data queries.

• Ensure proper oversight of investigational product receipt, handling, accounting, storage, and destruction.

• Support database release and fulfill unblinded monitor responsibilities as needed.

• Maintain knowledge of product, protocol, and therapy area, providing clinical guidance to investigators.

• Drive remediation for Quality Events and assist in the development and verification of corrective and preventive actions (CAPA) for audit observations.

⛳️ Requirements

• In-depth understanding of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) guidelines, and local regulations.

• A minimum of 3 years of relevant experience in monitoring clinical research sites.

• Fluency in English and the native language(s) of the country in which the candidate will work is required.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are mandatory.

• Bachelor’s degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or medical background, or equivalent qualifications.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional development and career advancement.

• Comprehensive health, dental, and retirement benefits.

• Supportive work environment with a focus on employee well-being.