Site Start up Associate II (Canada Regulatory Affairs)Apply: Remote: Canada: Full time: Posted 11 Days Ago: R6981Premier Research is looking for a Site Start up Associate II (Canada Regulatory Affairs) to join our Clinical Monitoring, Site Management and SSU team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.May serve as the primary point of contact for the Project Manager, Clinical Lead, Regulatory Start-up Manager (or designee) during start-up on allocated projects.

Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

Local Investigator Contract and Budget Negotiator (where applicable) - produces site-specific contracts from country template. Submit proposed contract and budget to the site for review.



Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country. What We Are Searching For: Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare skilled.

3+ years' of direct study start up experience Working knowledge of Health Canada Submissions / FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.

Detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements Proficient in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.

Ability to work independently with minimal supervision and complete work accurately, within quality expectations and agreed timelines.### Premier Research is more than a company - it’s a community furthering research to improve the lives of patients in critical need. Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.

Our dedication to biotech and specialty pharma is unlike any other.

- We provide our staff with innovative technologies and continuous learning.

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📌 Site Start up Associate II (Canada Regulatory Affairs) (Ottawa)
🏢 Premier Research Group
📍 Ottawa