Clinical Research Associate - Home-Based (Northeast)

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 Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.

• Contribute to the identification of new sites for clinical trials
• Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators.
• Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the Clinical Study Manager in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
• Execute site initiation and training, generate initiation visit report.
• Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
• Identify problems at sites; resolve issues and escalate as appropriate. 
• Complete preparation and generation of visit monitoring reports as per relevant SOP.
• Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
• Implement site close-out activities and generate site close-out report.
• Provide feedback on site performance for future trial site feasibility/selection
• Improve skills by timely completion performance of assigned global and local training.

• Bachelor’s Degree or higher in life sciences or equivalent 
• Minimum 2 – 4 years’ clinical site monitoring experience from CRO or Pharmaceutical company
• Comprehensive knowledge and understanding of ICH-GCP
• Bilingual (verbal and written) in English and French languages required
• Able and willing to travel up to 60% regionally (sites in Quebec City and Montreal)
• Able and willing to work on several protocols/therapy areas
• Experience in phase I-IV trials
• Working knowledge of Electronic Data Capture (preferred)
• Experience/working knowledge of the oncology disease area (preferred but not required)
• Experience of Centralized/Risk Based/Targeted monitoring (preferred)
• Experience of working within a metric based environment (preferred)
• Excellent attention to detail
• Highly developed time management and organizational skills 
• Focused on meeting study deliverables/targets
• Flexible and willing to adapt to changing priorities/timelines

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.

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**