Senior Clinical Research Associate

Senior Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate based in Canada.

This is an opportunity for an experienced clinical research professional to contribute to the successful delivery of Phase II and III clinical studies across Canada. You will take ownership of on-site monitoring activities while ensuring high standards of data quality, patient safety, and regulatory compliance. The role offers exposure to a broad range of clinical research activities and the opportunity to work closely with sites, vendors, and cross-functional project teams. You will serve as a key point of contact for clinical sites, supporting effective communication and study execution throughout the trial lifecycle. Your expertise will also contribute to feasibility activities, regulatory submissions, audits, and inspections. Working in a dynamic and collaborative environment, you will have the autonomy to manage priorities while partnering with experienced clinical research professionals. This role is particularly suited to someone looking to broaden their therapeutic experience and further develop their expertise in clinical research.

Accountabilities

• Conduct and document Site Initiation Visits (SIV), Routine Monitoring Visits (RMV), and Close-Out Visits (COV) at clinical trial sites.
• Perform comprehensive Case Report Form (CRF) reviews, source document verification, and query management to support data quality and protocol compliance.
• Manage ongoing communication with clinical sites and act as a key point of contact throughout study execution.
• Coordinate with internal support functions and external vendors to ensure smooth study delivery and timely resolution of operational matters.
• Communicate study progress, risks, issues, and site-related updates to internal project teams.
• Contribute to feasibility assessments and research activities supporting the selection and preparation of clinical trial sites.
• Support regulatory teams with the preparation of documentation required for study submissions.
• Prepare for and participate in audits and regulatory inspections, ensuring appropriate documentation and compliance.
• Plan and prioritize monitoring activities effectively while managing multiple sites, deadlines, and study requirements.
• Travel to clinical trial sites as required to support monitoring and study activities.

Requirements

• College or university degree in Life Sciences or a comparable combination of education, training, and relevant professional experience.
• Proven experience conducting independent on-site clinical monitoring activities.
• Hands-on experience across different types of monitoring visits, particularly within Phase II and/or Phase III clinical trials.
• Previous experience in oncology clinical research is considered an asset.
• Full professional proficiency in English, with strong written and verbal communication skills.
• Proficiency with Microsoft Office applications and the ability to maintain accurate clinical documentation.
• Strong organizational and time-management skills, with the ability to plan, multitask, and manage competing priorities in a dynamic environment.
• Excellent communication, collaboration, problem-solving, and stakeholder-management abilities.
• Ability to work independently while contributing effectively within cross-functional and geographically distributed teams.
• Willingness and ability to travel regularly to clinical trial sites.
• Valid driver's license.
• A proactive, detail-oriented approach and a strong commitment to clinical research quality, compliance, and patient safety.

Benefits

• Freelance opportunity supporting clinical research activities across Canada.
• Opportunity to further develop clinical monitoring and study management expertise.
• Exposure to Phase II and Phase III clinical trials across diverse therapeutic areas.
• Potential to broaden therapeutic-area experience, including opportunities to develop expertise in oncology.
• Collaboration with experienced clinical research, regulatory, project, and site teams.
• Exposure to feasibility activities, regulatory submissions, audits, and inspections.
• Dynamic and collaborative working environment with opportunities to expand your clinical research capabilities.
• Opportunity to take on meaningful responsibilities and further establish yourself as a clinical research expert.