Senior CRA-Oncology-Ontario

ICON; Toronto; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading company in clinical research is seeking a Senior Clinical Research Associate in Toronto. The role involves managing clinical trial activities, ensuring compliance with regulations, and maintaining stakeholder communication. Candidates should have a strong educational background, extensive monitoring experience, and excellent analytical skills.

Benefits

Annual leave

Health insurance

Retirement plans

Employee Assistance Programme

Life assurance

Flexible country-specific benefits

Qualifications

• 4+ years of clinical monitoring experience required.
• Knowledge of ICH and local regulatory authority regulations.
• Experience in coaching/mentoring other CRAs.

Responsibilities

• Manage operational site evaluation visits and ensure quality execution of studies.
• Communicate progress to study management and stakeholders.
• Ensure compliance with regulatory requirements.

Skills

Communication

Organizational Skills

Problem Solving

Data Analysis

Knowledge of ICH GCP

Education

Undergraduate degree in clinical, science, or health-related field

Licensed healthcare professional

Job description

As a Sr. CRA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing skills.
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Strong planning & organizational skills, and the ability to work efficiently and effectively.
• Proactive, conscientious and precise in delivery of quality work even when under pressure.
• Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner.
• Flexible with high learning and change agility.
• Knowledge of local regulations, IND/ICH GCP guidelines.
• Available and willing to travel as required by the job.
• Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team.
• Engage and maintain good written and verbal communication with external stakeholders to ensure effectiveness.
• Accountable for local activities required in setup and for high quality execution of studies; seek managerial or other experienced support as appropriate.
• Perform operational site evaluation visits, study initiation visits, monitoring visits at the required frequency, and site close-out.
• Determine the feasibility of the study protocol considering study complexity.
• Confirm staff availability, suitable clinical facilities, and potential for patient recruitment.
• Ensure ability to comply with ICH GCP and other requirements for clinical studies.
• Work with study staff to carry out local study/site level risk assessments.
• Participate in global investigator and monitor meetings as appropriate, and assist in organizing local investigator meetings.
• Maintain good relationships with sites, ensure critical study timelines are met, and recruitment targets achieved.
• Ensure investigators and staff understand their roles regarding regulatory requirements (ICH-GCP).
• Work with sites to address data queries timely and verify data entered into CRFs against medical notes.
• Ensure investigators and site staff receive safety reports and new safety information promptly.
• Ensure accuracy of safety data (AEs, SAEs) and report to relevant departments within required timelines.
• Complete monitoring visit reports within agreed timelines.
• Keep clinical study tracking databases current (e.g., e-track, Veeva, RAMOS).
• Ensure study supplies are available and properly accounted for at sites, and unused supplies are destroyed appropriately.
• Maintain sponsor study records in inspection-ready condition and archive records as needed.

Education required:

• Undergraduate degree in clinical, science, or health-related field from an accredited institution; or a licensed health-care professional (e.g., registered nurse); or equivalent work experience preferred.

Skills Required:

• Fluent in reading, writing, and speaking English; fluency in host country language required.
• 4+ years of clinical monitoring experience.
• Knowledge of ICH and local regulatory authority regulations regarding drugs.
• Experience in clinical research and monitoring all trial components.
• Experience in coaching/mentoring other CRAs.

What ICON can offer you:

Our success depends on the quality of our people. We build a diverse culture that rewards high performance and nurtures talent. ICON offers competitive salaries and benefits focused on well-being and work-life balance, including various leave entitlements, health insurance, retirement plans, and additional perks.

Visit our careers website to learn more: https://careers.iconplc.com/benefits

ICON is committed to inclusion & belonging, providing an inclusive, accessible environment for all candidates. We do not discriminate and provide reasonable accommodations upon request.

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we're looking for.