Clinical Research Associate - Canada

Syneos Health, Inc.

Job Overview

Location

CAN-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
• Verify that informed consent processes are properly documented for each subject/patient and ensure confidentiality of patient data is maintained at all times.
• Conduct source document reviews and verify accuracy and completeness of clinical data entered in case report forms (CRFs) by comparing with original source documents and medical records.
• Apply remote and on-site query resolution techniques to address data discrepancies and drive resolution within agreed timelines, providing guidance to site staff as needed.
• Monitor and verify investigational product (IP) inventory, storage, security, dispensing, and administration in alignment with protocol requirements and regulatory standards.
• Review and reconcile Investigator Site Files (ISF) with the Trial Master File (TMF), ensuring all essential documents are accurate, timely, and complete per local regulations.
• Document all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with company SOPs and Clinical Monitoring/Site Management Plans.
• Support subject recruitment and retention strategies, and enter all observations, status updates, and action items into required tracking systems.
• Manage site-level activities to meet project objectives, timelines, and deliverables, adapting quickly to shifting priorities and evolving study requirements.
• Serve as primary liaison between the sponsor and site personnel, ensuring all site staff are trained and compliant with applicable regulatory and company requirements.
• Prepare for and attend Investigator Meetings and sponsor-facing clinical meetings; may lead or participate in global clinical monitoring and project team meetings.
• Ensure sites are audit-ready by providing guidance on compliance standards and supporting preparation for regulatory audits and follow-up actions.
• Mentor and train junior Clinical Research Associates (CRAs), including conducting training and sign-off visits as assigned.
• For Real World Late Phase (RWLP) roles: Support sites throughout the entire study lifecycle from identification to close-out; perform chart abstraction and data collection; collaborate with Sponsor, medical science liaisons, and local country staff; identify operational efficiencies and process improvements; develop country-specific informed consent forms; work with RWLP Regulatory team to ensure compliance with updated regulatory information; participate in bid defense meetings.
• Maintain current knowledge of ICH/GCP guidelines, local regulations, and company procedures to ensure consistent adherence across all monitoring activities.
• Utilize electronic data capture systems and other clinical trial technologies to support efficient data review and study execution.
• Manage up to 75% travel requirement for on-site monitoring visits as needed.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements
• Demonstrated ability to manage up to 75% travel on a regular basis
• Strong computer skills and proficiency with clinical trial technologies
• Excellent communication, presentation, and interpersonal skills
• Basic critical thinking skills to evaluate site performance and data integrity

🏖️ Benefits

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Commitment to a Total Self culture promoting authenticity and belonging
• Diversity of thoughts, backgrounds, cultures, and perspectives fostered globally

Skills & Technologies

GCP

Junior

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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