Senior CRA

PRA International; Alberta; On-site; CAD 80,000 - 110,000; Full time

Job summary

PRA International seeks a Senior Clinical Research Associate to manage clinical trials efficiently. This role involves coordinating study evaluations, ensuring compliance with regulations, and maintaining effective communication with stakeholders. Candidates must possess relevant qualifications and clinical monitoring experience. Join a leading organization dedicated to creating a diverse and inclusive workplace.

Benefits

Annual leave entitlements

Health insurance options

Retirement plans

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Gym discounts

Qualifications

• At least 4 years of clinical monitoring experience.
• Licensed healthcare professional preferred.
• Knowledge of local regulatory regulations regarding drugs.

Responsibilities

• Manage study site evaluations, initiation, monitoring, and closure.
• Ensure compliance with regulatory requirements and resolve issues promptly.
• Maintain communication with stakeholders, ensuring timelines and data quality.

Skills

Fluent in English

Clinical monitoring experience

Knowledge of ICH regulations

Coaching/mentoring CRAs

Education

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

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:

• Communicate effectively in English and the local language (if applicable), with good presentation, negotiation, and influencing skills.
• Manage multiple priorities and responsibilities with increasing scope and complexity.
• Plan and organize efficiently, working effectively under pressure.
• Analyze issues, escalate appropriately, solve problems, and resolve conflicts promptly.
• Be flexible, with high learning agility and adaptability to change.
• Understand local regulations, IND/ICH GCP guidelines.
• Travel as required by the job.
• Report study progress and escalate issues to the study management team.
• Maintain effective communication with external stakeholders.
• Ensure local activities for study setup and execution are performed with high quality, seeking support when needed.
• Conduct operational site evaluations, study initiation, monitoring visits, and site close-out.
• Assess study protocol feasibility considering complexity, staff availability, facilities, and patient population.
• Ensure compliance with ICH GCP and study requirements.
• Work with study staff to manage local study/site risks.
• Participate in global investigator and monitor meetings, and organize local investigator meetings as needed.
• Maintain good relationships with sites, ensuring timelines, recruitment, data quality, and milestones are achieved.
• Ensure investigators and staff understand their roles concerning regulatory requirements.
• Work with sites to address data queries promptly and verify data accuracy.
• Distribute safety reports and ensure timely safety data entry and reporting.
• Complete monitoring visit reports on time.
• Keep clinical study tracking databases current.
• Manage study supplies, ensuring availability and proper accountability.
• Ensure sponsor study records are inspection-ready and archived appropriately.

Qualifications

You are:

Education required:

• Undergraduate degree or equivalent in clinical, science, or health-related field from an accredited institution; licensed healthcare professional preferred.

Skills Required

• Fluent in English and the host country language.
• At least 4 years of clinical monitoring experience.
• Knowledge of ICH and local regulatory regulations regarding drugs.
• Experience in monitoring all trial components from PSSV to COV.
• Experience in coaching/mentoring other CRAs.

What ICON can offer you:

ICON values high performance and talent development, offering competitive salaries and benefits, including:

• Annual leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme
• Life assurance
• Optional benefits like childcare vouchers, gym discounts, and more.

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

ICON promotes inclusion and diversity. We are committed to a workplace free of discrimination. If you need accommodations during the application process, please inform us through the provided link: https://careers.iconplc.com/reasonable-accommodations

We encourage all interested candidates to apply, regardless of whether they meet every requirement, as your skills and experience might be a great fit.