Senior CRA

PRA International; Toronto; On-site; CAD 80,000 - 120,000; Full time

Job summary

A leading clinical research organization seeks a Senior Clinical Research Associate (Sr. CRA) in Toronto. The ideal candidate will have a degree in a health-related field and 4+ years of clinical monitoring experience, ensuring compliance and effective communication with stakeholders throughout the study process. ICON offers a diverse culture with a competitive salary and various employee benefits that emphasize work-life balance.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning options

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 is necessary.
• Fluency in English and host country language required.

Responsibilities

• Manage local activities in study setup and execution.
• Perform operational site evaluation visits, study initiation visits, and monitoring visits.
• Ensure compliance with ICH GCP and study requirements.

Skills

Clinical monitoring

Communication skills

Organizational skills

Problem-solving

Knowledge of regulations

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

What you will be doing:

• Possess strong written and verbal communication skills in English and the local language (if applicable), with good presentation, negotiation, and influencing abilities.
• Effectively manage multiple priorities and responsibilities of increasing scope and complexity.
• Demonstrate strong planning & organizational skills, working efficiently and effectively.
• Be proactive, conscientious, and precise in delivering quality work even under pressure.
• Analyze and escalate issues appropriately, solve problems, and resolve conflicts in a timely manner.
• Be flexible with high learning agility and adaptability to change.
• Have knowledge of local regulations, IND/ICH GCP guidelines.
• Be available and willing to travel as the job requires.
• Communicate progress and relevant information or escalate issues to the study management team.
• Maintain effective written and verbal communication with external stakeholders to ensure effectiveness.
• Be accountable for local activities in study setup and execution, seeking support from management or experienced staff as needed.
• Perform operational site evaluation visits, study initiation visits, monitoring visits, and site close-out as required.
• Assess the feasibility of the study protocol considering complexity, staff availability, clinical facilities, and patient recruitment potential.
• Ensure compliance with ICH GCP and study requirements.
• Collaborate with study staff to carry out local risk assessments.
• Participate in global investigator and monitor meetings, facilitating investigator participation and organizing local meetings as needed.
• Maintain good relationships with sites, ensuring critical study timelines, recruitment targets, data quality, and milestones are achieved.
• Ensure investigators and staff understand their roles regarding regulatory requirements.
• Work with sites to address data queries promptly, verifying data accuracy against medical notes.
• Ensure timely receipt of safety reports and safety information by investigators and staff.
• Maintain accurate safety data (AEs, SAEs) and report within required timeframes.
• Complete monitoring visit reports within agreed timelines.
• Keep clinical study tracking databases current (e.g., e-track, Veeva, RAMOS).
• Ensure timely availability and accountability of study supplies at sites, managing unused supplies appropriately.
• Maintain sponsor study records in inspection-ready condition and archive records as needed.

Qualifications

You are:

Education required:

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

Skills Required

• Fluent in reading, writing, and speaking English; fluency in the host country language required.
• At least 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 prioritize building a diverse culture that rewards high performance and nurtures talent. Besides a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements.
• A range of health insurance options for you and your family.
• Retirement planning options.
• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to support professionals.
• Life assurance.
• Flexible country-specific benefits, such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments.

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits. ICON values inclusion & belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment. If you need accommodations during the application process, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations. We encourage you to apply regardless of whether you meet all requirements, as you may be the perfect fit for this or other roles at ICON.