Study Start Up Associate

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