Senior CRA - Bilingual

Pharmaceutical Research Associates, Inc; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking organization dedicated to shaping the future of clinical development. This role offers an exciting opportunity to manage Oncology trials, ensuring compliance and data integrity through effective site management and monitoring. You will be pivotal in fostering relationships with key sites, conducting training, and supporting regulatory inspections. With a commitment to diversity and inclusion, this innovative firm provides a supportive environment where your contributions will significantly impact clinical research. If you have a passion for excellence and a drive to make a difference, this position is perfect for you.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• 5+ years of experience monitoring Oncology trials independently.
• Expertise in GCP and Oncology monitoring techniques.

Responsibilities

• Perform site management activities to support Oncology site success.
• Conduct remote and on-site monitoring visits to ensure data integrity.

Skills

Oncology trial monitoring

Good Clinical Practices (GCP)

Risk-Based Monitoring

Bilingual (French/English)

Site relationship management

Education

Bachelor’s degree in a scientific field

Tools

Veeva systems

Job description

Overview

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.

Responsibilities

What you will be doing:

• Perform site management activities to support Oncology site success and maintain a continuous state of inspection readiness
• Act as the primary contact and facilitate efficient communications between the 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 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 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

You are:

• 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 GCP 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 an FSP (or in-house) monitoring model is preferred
• Willing to travel up to 50%
• Bilingual (French/English) - sites located in Ontario and Quebec

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.