Site Start-up Associate II (Health Canada CTA Submissions Expert)
- Canada
Full-time
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Job details
- Job type
- Full-time
- Experience
- 3+ years' of direct study start up experience
- Posting language
- English
- Posted
Original 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.
What You'll Be Doing
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.
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.
- 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.
More about this job
Responsibilities
Forecast and manage regulatory submission and approval timelines, prepare and submit Health Canada CTA applications and other required local approvals, and resolve country-level ethics committee or regulatory issues. Collect and review essential documents, support informed consent and patient-document preparation, and negotiate site budgets and contracts through execution.
Requirements
Requires an undergraduate degree or international equivalent in a clinical, science, or health-related field, or a licensed healthcare professional, plus at least three years of direct study start-up experience. Candidates should have working knowledge of relevant regulatory frameworks and detailed country-specific trial and contract requirements, along with informed consent document expertise and the ability to work independently and meet quality and timeline expectations.
Skills
- Health Canada CTA Submissions
- Clinical Trial Start-Up
- Regulatory Submissions
- Submission Timeline Forecasting
- Essential Document Collection and Review
- ICH/GCP Compliance
- Informed Consent Form Development
- Site Contract Negotiation
- Clinical Trial Budget Negotiation
- Regulatory Issue Resolution
- Country-Specific Regulatory Requirements
- Drug and Device Development
- Clinical Monitoring
- Project Coordination
- Quality Review
- Independent Work
Visa sponsorship
Not detected in the job text
Categories
- Healthcare
- Science & Research
- Legal
- Management & Leadership
Keywords
- Health Canada
- Clinical Trial Application
- CTA Submissions
- Clinical Trial Start-Up
- Regulatory Authorities
- FDA Guidance Documents
- EU Directives and Regulations
- Local Regulations
- ISO 14155
- ICH/GCP
- Drug Development
- Medical Device Development
- Clinical Monitoring
- Ethics Committee
- Institutional Review Board
- Clinical Trial Essential Documents
- Informed Consent Forms
- Patient Documents
- Site Contracts
- Contract Negotiation
- Budget Negotiation
- Submission Timelines
- Regulatory Compliance
- Site Management