Senior Clinical Research Associate - Toronto

As a Senior Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

As the Senior Clinical Research Associate, you will monitor the progress of clinical studies at investigative sites or remotely (Western Canada - Vancouver/British Columbia), and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. 

• Must have a strong monitoring background in Oncology
• Applies knowledge of PRA’s policies and procedures
• Demonstrates excellent written and oral communication
• Demonstrates excellent knowledge of ICH/GCP
• Displays ability to manage investigative sites to facilitate trial deliverables
• Demonstrates ability to escalate issues appropriately 
• Conducts monitoring to confirm subject safety and data ntegrity
• Describes and demonstrates the principals of IP accountability
• Identifies scientific misconduct at the site level
• Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
• Mentors CRAs new to the position or company
• Serves as an observation visit leader
• Conducts monitoring evaluation visits
• Assists team lead in the development of trial tools or documents

Qualifications Needed:

• Based in the Greater Toronto Area, ON
• Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• Have a minimum of 3 years’ experience in monitoring pharmaceutical industry clinical trials
• Knowledge of several therapeutic areas,  with oncology an asset but not a requirement.
• Analytical/risk-based monitoring experience is an asset
• Ability to actively drive patient recruitment strategies at assigned sites
• Ability to partner closely with investigator and site staff to meet all of our study timelines
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.  Strong team member and self-starter with the ability to work independently.
• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• Need to travel up to 50%

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.