Senior Clinical Research Associate - Oncology Early Development - Toronto
The Sr. Clinical Research Associate (Sr. CRA) willbe responsible forperforming investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, andinspectionreadiness at the clinical investigative sites.
Responsibilities:
Perform site management activities to support client's Oncology site success andmaintaina continuous state of inspection readiness
Act as the primary contact andfacilitateefficient communications between the client clinical trial team and the sites
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities andsubmit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics,issuesand action items to detect trends and ensure prompt resolution
Independentlydetermineroot causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sitescomply withthe protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs)and regulations
Support sites and the client during regulatory inspections
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Qualifications
Bachelors degree (scientific field preferred)
5+ yearsmonitoringOncology trials independently conducting on-site and remote monitoring visits
1+ years early development trial experience
Solidtumorclinical trial experience is preferred
Experience utilizing Veeva systems is preferred
Demonstrated experience developing/maintainingsite relationships and securing compliance
ExpertiseinGxPsand Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites frominitialengagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Experience working within a Functional Services (or in-house) monitoring model is preferred
Bilingual (French and English) highly preferred but not required
Located in Toronto. Willing to travel up to 50%
Does not require sponsorship to work in Canada.
