Senior/Clinical Research Associate

The role

The Senior/Clinical Research Associate handles complex clinical trial assignments including start-up, study implementation, and on-site monitoring. This role involves site management, supporting Clinical Trial Managers, and mentoring junior staff.

What you will do

• Oversee study site management to ensure patient safety and data quality.
• Provide guidance towards audit readiness and support audit preparation.
• Maintain study specific trial management tools and status reports.
• Manage site start up procedures including feasibility, recruitment, and regulatory submissions.
• Conduct site visits including pre-study, initiation, routine monitoring, and close-out.
• Perform Monitoring Oversight Visits to assess other CRA team members.
• Document activities via confirmation letters, follow-up letters, and trip reports.
• Review Investigator Site File and reconcile with Trial Master File.
• Perform investigational product inventory, reconciliation, and storage review.
• Identify and process Serious Adverse Events.

Required qualifications

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline.
• Minimum of 3.5 years of on-site monitoring experience.
• Oncology experience.
• Global Clinical Trial experience.
• High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint).
• Customer service demeanour.
• Demonstrate flexibility and teamwork.
• Ability to focus on detail for extended periods of time, high attention to accuracy.
• Fluency in English communication, verbally and in writing.
• Working knowledge of the drug development process.
• Travelling required (60-70%)

Nice to have

• Solid experience in clinical research or related experience.
• Excellent organizational skills.
• Ability to work efficiently in a remote work environment.

About the company

Precision for Medicine is a CRO that integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences. They have a strong focus on Oncology and Rare Disease.