What are the responsibilities and job description for the Senior Clinical Research Associate/CRA - FSP position at Jobgether?
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 (CRA) - FSP based in Canada.
This is a field-based clinical operations role focused on ensuring the successful execution of clinical trials through high-quality site monitoring, patient safety oversight, and strong investigator site relationships. You will act as the primary point of contact for assigned study sites, supporting them from activation through close-out while ensuring compliance with ICH-GCP, local regulations, and sponsor requirements. The role requires a strong balance of scientific understanding, operational discipline, and relationship management to drive site performance, enrollment success, and data quality. You will work closely with cross-functional study teams, including site care partners and clinical operations stakeholders, to resolve issues and maintain trial timelines. With a strong focus on oncology and other complex therapeutic areas, this role plays a key part in safeguarding patient safety and ensuring high-quality clinical data. This is a remote position within Canada requiring up to 60–80% travel.
- Conduct site monitoring activities including site initiation, routine monitoring visits, and close-out visits in accordance with the Study Monitoring Plan and applicable regulations.
- Serve as the primary liaison for assigned investigator sites, ensuring effective communication and timely resolution of site-level issues.
- Ensure compliance with ICH-GCP, study protocols, and regulatory requirements while safeguarding patient safety and data integrity.
- Support site activation, recruitment, and enrollment activities in collaboration with study teams and site care partners.
- Monitor adverse events (AEs) and serious adverse events (SAEs), ensuring timely reporting and resolution in coordination with safety teams.
- Maintain accurate and timely study documentation, including monitoring reports, TMF updates, follow-up letters, and site communication records.
- Identify, document, and resolve site issues, developing corrective and preventive actions (CAPAs) where required.
- Oversee investigational product handling at site level, including storage, accountability, and compliance with protocol requirements.
- Support database lock activities and contribute to overall study execution quality and timelines.
- Participate in audit and inspection readiness activities, including CAPA implementation and quality event remediation.
Requirements:
- Minimum 3 years of clinical research monitoring experience, preferably including exposure to oncology or other complex therapeutic areas.
- Strong knowledge of ICH-GCP guidelines, clinical trial operations, and applicable regulatory requirements (FDA and local authorities).
- Bachelor’s degree in life sciences or related field (nursing, pharmacy, or medical background preferred).
- Proven ability to manage investigator site relationships and resolve operational issues independently.
- Strong understanding of clinical trial processes from site initiation through close-out.
- Excellent communication skills with fluency in English and local language(s) where applicable.
- Willingness and ability to travel up to 60–80% as required.
- Valid driver’s license and passport (if applicable for travel).
- Strong organizational skills with the ability to manage multiple sites and priorities simultaneously.
- Proactive, detail-oriented, and capable of working independently in a remote environment.
Benefits:
- Competitive compensation aligned with senior clinical research roles
- Remote work flexibility across Canada with significant field-based activity
- Opportunity to work on global clinical trials in oncology and other advanced therapeutic areas
- Exposure to leading clinical research methodologies and cross-functional study teams
- Strong professional development within a global clinical research organization
- Comprehensive benefits package including healthcare coverage and employee support programs
- Opportunity to contribute directly to improving patient access to innovative therapies.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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