Study Start Up Associate II

Posted 5 days ago

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About the role

  • Study Start Up Associate II facilitating initiation of clinical trials in regulatory compliance at ICON. Ensuring approvals and developing study documents within a diverse team.

Responsibilities

  • Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
  • Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  • Maintaining accurate and up-to-date records of regulatory submissions and approvals.
  • Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
  • Participating in study start-up meetings and providing input on regulatory requirements and timelines.

Requirements

  • Bachelor's degree in life sciences or a related field
  • Previous experience in clinical research or regulatory affairs is preferred
  • 1+ years of Study Start-Up (SSU) experience
  • Strong attention to detail and organizational skills
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
  • Advanced French communication skills, including fluent verbal interactions and strong written proficiency for study documents and regulatory communications.

Benefits

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Job title

Job type

Full Time

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

HybridMontrealCanada

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