Senior Clinical Research Associate

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

📋 Description

• Oversee, provide, and/or execute comprehensive clinical site monitoring services for one or more projects, which may include multiple services, intricate studies, and international projects.

• Design and manage project monitoring services, encompassing training, site/patient recruitment, site data/document management, project site budgets, and regulatory submissions in accordance with SOPs, study protocols, and GCP best practices.

• Act as the principal point of contact between CRAs and the project team as the Lead CRA.

• Engage in the creation of project plans, protocols, CRFs, communications, monitoring forms, documents, and tools.

• Conduct and document both onsite and remote monitoring visits, including close-out, qualification, and initiation visits.

• Evaluate study data against source documents, address or escalate data queries, and ensure adherence to study requirements.

• Coordinate the shipment and delivery of investigational products, laboratory supplies, ePROs, and study documentation.

• Train site personnel on protocols, study plans, systems, and ICH-GCP guidelines.

• Review ISF and TMF for accuracy, timeliness, and completeness; request any missing site documents.

• Serve as the main contact for questions and issues from investigational sites.

• Monitor site issues, action items, and protocol deviations until they are resolved.

• Facilitate site communications and provide updates on projects, regulatory status, and study progress.

• Assist with site activation, regulatory document review/localization/translation, and study initiation.

• Enhance patient recruitment efforts and assist sites in achieving recruitment milestones.

• Participate in audits, inspections, study meetings, teleconferences, and Investigator meetings.

• Mentor and guide CRA I and II personnel.

• Conduct CRA assessment visits, co-monitoring visits, and oversee the visit sign-off processes.

• Engage in CRA interviews, process improvement initiatives, and the development of best practices.

⛳️ Requirements

• A minimum of a college diploma or degree.

• 4–6 years of relevant experience.

• Willingness to travel regularly to clinical sites.

• Proficiency with EDC systems such as Medidata Rave and Oracle InForm.

• Knowledgeable in IRT, eTMF, CTMS, and Microsoft Office Suite.

• Ability to travel up to 40–60%, depending on project assignments and site locations.

• Strong interpersonal and problem-solving abilities.

• Capability to work independently as well as collaboratively within cross-functional teams.

• Excellent communication and organizational skills.

• Detail-oriented with a strong sense of urgency.

• Proficient in both English and French.

🏝️ Benefits

• Full-time, Permanent position.

• Bonus opportunities.

• Home-based work arrangement.