Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology Early Development - Toronto

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing 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, and inspection readiness at the clinical investigative sites. 

Responsibilities: 

• Perform site management activities to support client's Oncology site success and maintain a continuous state of inspection readiness 

• Act as the primary contact and facilitate efficient 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 and submit/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, issues and action items to detect trends and ensure prompt resolution 

• Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans 

• Deliver training to ensure sites comply with the 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 

• Bachelor’s degree (scientific field preferred) 

• 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits 

• 1+ years early development trial experience  

• Solid tumor clinical trial experience is preferred 

• Experience utilizing Veeva systems is preferred 

• Demonstrated experience developing/maintaining site relationships and securing compliance 

• Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology 

• Experience collaborating with sites from initial engagement 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.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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