Site Start-Up Specialist

Job summary

Own site start-up activities from initiation through activation, ensuring regulatory requirements are met. Prepare and coordinate regulatory submissions and approvals, maintain accurate records, and support the development and review of study documents.

Job details

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Site Start-Up Specialist with ICON, you will facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. You will be responsible for the end-to-end Site Start-Up (SSU) ownership from start-up through activation. What You Will Do: Your role will involve delivering site start-up and activation work to a high standard, working closely with your team and stakeholders. Key responsibilities include: 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. Oversee and manage regulatory document collection, review and submission Your Profile: You will bring relevant site start-up and activation experience, along with the following qualifications and skills. Required qualifications and experience: minimum of a HS diploma, but a BS/BA degree in life sciences or related field preferred clinical research or regulatory affairs experience in CRO or Pharma field (or strong, relevant SMO experience with direct site activation ownership) U.S. site experience preferred ability to work in Canada without sponsorship Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and well-being programs including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programs and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply.

What you’ll do

Own site start-up activities from initiation through activation, ensuring regulatory requirements are met. Prepare and coordinate regulatory submissions and approvals, maintain accurate records, and support the development and review of study documents.

Requirements

A high school diploma is the minimum requirement; a bachelor's degree in life sciences or a related field is preferred. Candidates should have clinical research or regulatory affairs experience in a CRO or pharmaceutical company, or relevant SMO experience with direct site activation ownership; U.S. site experience is preferred, and the candidate must be legally able to work in Canada without sponsorship.

Benefits

• Medical Insurance
• Dental Insurance
• Vision Coverage
• Retirement and Pension Plans
• Life Assurance
• Disability Coverage
• Employee Assistance Programs
• Wellbeing Resources
• Learning and Development Opportunities

Listed skills

• Regulatory Compliance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Site Start-Up
• Site Activation
• Clinical Research
• Regulatory Affairs
• Regulatory Document Preparation
• Clinical Trial Applications
• Ethics Committee Submissions
• Regulatory Document Collection and Review
• Regulatory Submissions
• Stakeholder Coordination
• Study Document Development
• Protocol Development
• Informed Consent Forms
• Investigator Brochures
• Regulatory Compliance
• Recordkeeping

Job areas

• Healthcare
• Science & Research
• Administrative

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