Senior CRA / CRA II

ICON plc; Montreal; On-site; CAD 60,000 - 80,000; Full time

Job summary

An established industry player in healthcare intelligence is seeking a Clinical Research Associate to join their dynamic team. In this role, you will be responsible for setting up and monitoring clinical studies, ensuring compliance with regulations, and contributing to the advancement of patient care. You will work closely with a dedicated team, fostering an inclusive environment that drives innovation. If you are passionate about making a difference in clinical development and possess the necessary experience and bilingual skills, this opportunity is perfect for you. Join us in shaping the future of healthcare research!

Qualifications

• 12+ months of monitoring experience as a CRA for a sponsor or CRO.
• Must be bilingual in French and English.

Responsibilities

• Set up and monitor studies, complete reports, and maintain documentation.
• Submit protocol and consent documents for ethics/IRB approval.

Skills

Monitoring Experience

Bilingual (French and English)

Communication Skills

Knowledge of ICH-GCP Guidelines

Ability to Work Under Tight Deadlines

Education

College Degree in Medicine or Science

Job description

CRA II

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.

Requirements:

• 12+ months of monitoring experience as a CRA for a sponsor or CRO
• Must be bilingual in French and English

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The role:

• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

You will need:

• 12 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication
• Ability to work to tight deadlines
• Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

ICON is an equal opportunity and inclusive employer and 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.