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