Site Start-up Associate II (Health Canada CTA Submissions Expert)
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Posted by Premier Research International LLC on the hiring system it uses for its careers page; applications go straight to the company.
Can I apply?
- Full-time
- Remote from Canada
- Work permit not stated
Site Start-up Associate II at Premier Research (Canada), full-time per the ATS label; the description does not state workplace or location within Canada.
Core duties: prepare and submit Health Canada CTA applications and other local regulatory or hospital approvals, negotiate local investigator contracts and budgets, and review informed consent and patient documents against ICH/GCP.
Eligibility: undergraduate degree (or international equivalent) in a clinical, science, or health field, or a licensed healthcare professional, plus 3+ years of direct study start-up experience.
Work-authorization, salary, and remote eligibility are not stated; confirm these with the employer before applying.
From the posting
- workplace
ATS workplace type: remote
- remote eligible countries
ATS location: Canada
- locations
ATS location: Canada
- employment types
full_time
- seniority
Site Start-up Associate II
- job function
Prepares and submits Health Canada CTA Applications
- role family
Clinical Monitoring, Site Management and SSU team
- skills
Working knowledge of Health Canada Submissions / FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations
- years experience min
3+ years' of direct study start up experience
- education required
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional.
- actionable
Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met
- scam risk
Local Investigator Contract and Budget Negotiator. Negotiates budget and contract with site and via Contracts Lead with Sponsor
Job description
Premier Research is looking for a Site Start-up Associate II (Health Canada CTA Submissions Expert) 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.
- Your ideas influence the way we work, and your voice matters here.
- As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing:
- Forecasts submission/approval timelines and ensures they are adhered to. Provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. 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 Health Canada CTA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level.
- 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. 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 professional.
- 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.
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