Study Start Up Associate at ICON plc

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:

• 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.

Your Profile:

• You will bring relevant site start-up and activation experience, along with the following qualifications and skills

Required qualifications and experience:

• Bachelor's degree in Life Sciences or a related field.
• Demonstrated experience within Study Start-Up / Site Activation in a clinical research environment.
• Proven experience independently completing CTF 1, CTF 2 and CTF 3 submissions from start to finish.
• Experience preparing, reviewing, coordinating and submitting all required documentation across the CTF submission stages.
• Strong understanding of regulatory and documentation requirements associated with clinical trial start-up and site activation.
• Experience coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal study teams, as applicable.
• Ability to independently manage multiple studies, sites, submission requirements, timelines and follow-up activities in a fast-paced environment.
• Strong organisational skills and attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Willingness to work from the office 2–3 days per week.

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 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