Senior Clinical Research Associate
New
Remote work flexibility across CanadaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 3+ years
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.
Responsibilities
- 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.
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