Senior CRA-Oncology-Ontario

PRA Health Sciences; Toronto; On-site; CAD 80,000 - 100,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Clinical Research Associate (Sr. CRA) to manage local study activities. The role involves overseeing site setups, compliance, and working closely with various stakeholders. Candidates should have relevant academic qualifications along with several years of experience in clinical monitoring. PRA Health Sciences values diversity and offers a comprehensive benefits package that includes competitive salary and various perks.

Benefits

Competitive salary

Health insurance

Retirement plans

Employee Assistance Programme

Flexible benefits

Qualifications

• 4+ years of clinical monitoring experience required.
• Knowledge of ICH and local regulatory guidelines is crucial.
• Licensed healthcare professional preferred.

Responsibilities

• Accountable for local activities in study setup and execution.
• Perform site evaluations and monitoring visits.
• Ensure compliance with ICH GCP and study requirements.

Skills

Communication

Negotiation

Problem Solving

Planning

Analytical Skills

Organizational Skills

Adaptability

Education

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

Job description

Overview

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

Responsibilities

• Strong written and verbal communication skills in English and the local language (if applicable), along with 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 delivering quality work even under pressure.
• Effective at analyzing and escalating issues appropriately, solving problems, and resolving conflicts in a timely manner.
• Flexible with high learning agility and adaptability to change.
• Knowledge of local regulations, IND/ICH GCP guidelines.
• Willingness and availability to travel as required.
• Communicate progress and relevant information or escalate issues to the study management team.
• Maintain good communication with external stakeholders to ensure effectiveness.
• Accountable for local activities in study setup and execution, seeking support as needed.
• Perform operational site evaluation visits, study initiation visits, monitoring visits, and site close-out.
• Assess study protocol feasibility considering study complexity.
• Confirm staff availability, clinical facilities, and patient recruitment potential.
• Ensure compliance with ICH GCP and study requirements.
• Collaborate with study staff to carry out risk assessments at the site level.
• Participate in global investigator and monitor meetings, and facilitate investigator participation.
• Maintain good relationships with sites, ensuring study timelines, recruitment targets, data quality, and milestones are met.
• Ensure investigators and staff understand their roles regarding regulatory requirements.
• Work with sites to address data queries promptly and verify data accuracy.
• Ensure timely receipt of safety reports and information, and accurate safety data collection.
• Complete monitoring visit reports within agreed timelines.
• Keep study tracking databases current.
• Ensure availability and proper management of study supplies, and maintain records for inspection readiness.

Qualifications

Education:

• Undergraduate degree or equivalent in clinical, science, or health-related fields; licensed healthcare professional preferred.

Skills:

• Fluent in English and the host country language.
• 4+ years of clinical monitoring experience.
• Knowledge of ICH and local regulatory regulations regarding drugs.
• Experience in monitoring all trial components.
• Experience in coaching or mentoring other CRAs.

What ICON offers:

We prioritize building a diverse culture that rewards high performance and nurtures talent. Benefits include competitive salary, various leave entitlements, health insurance, retirement plans, Employee Assistance Programme, life assurance, and flexible benefits such as childcare vouchers, gym memberships, and more.

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

ICON values inclusion & belonging, providing an accessible environment for all. We are committed to equal opportunity employment and encourage applications from all qualified candidates. For accommodations during the application process, please contact us through the provided link: https://careers.iconplc.com/reasonable-accommodations

If you're interested but unsure if you meet all requirements, we encourage you to apply — you might be the perfect fit for this or other roles at ICON.