Senior Clinical Research Associate/CRA - FSP in Canada Creek, Nova Scotia at Jobgether
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Job Description
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.
- 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.
- 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.