Site Start-up Associate II (Health Canada CTA Submissions Expert)

@ Premier Research

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Canada

Temps plein3+ ans d’expérience

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Premier Research is hiring a full-time Site Start-up Associate II to lead Health Canada CTA submissions within its Clinical Monitoring, Site Management and SSU team. The role forecasts submission and approval timelines, prepares regulatory filings, and negotiates local investigator contracts and budgets for biotech, medtech and specialty pharma sponsors. The posting asks for a clinical, science or health degree and 3+ years of study start-up experience.

Responsabilités :

Forecast submission and approval timelines and escalate delays
Prepare and submit Health Canada CTA applications
Review essential study documents for regulatory compliance
Negotiate local investigator budgets and contracts
Review and adapt informed consent forms and patient documents

Résumé des exigences :

Undergraduate degree in a clinical, science or health field, or licensed healthcare professional
3+ years of direct study start-up experience
Working knowledge of Health Canada, FDA, EU and ISO 14155 regulations
Detailed knowledge of country-specific clinical trial requirements
Proficiency in informed consent form development and review
Ability to work independently with minimal supervision

Source et dates

Type de source non vérifié · apify-linkedin

Date publiée par l’employeur: Non fourni
Première détection par notre source: 2026-11-14
Mise à jour du dossier source: 2026-11-14

Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.

Détails du poste

Niveau	Intermédiaire
Domaine	Assurance qualité
Expérience	3 an(s) et plus
Heures par semaine	40 (estimé)
Milieu de travail	Bureau, Domicile
Position	Surtout assis
Exigences physiques	physique faible · ordinateur élevé
Langues	English
Formation	Baccalauréat (exigé)
Domaines d’études	Clinical, Science, Health-related field
Avantages mentionnés	Horaire flexible

Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.

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Premier Research

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Champ	Valeur
Offres sur Jobsy	1

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.