Study Start Up Associate

About the role

ICON Strategic Solutions is hiring a Study Start Up Associate in Johannesburg. Working in a sponsor-dedicated model, the role facilitates the initiation of clinical trials while ensuring compliance with regulatory requirements, contributing to the development of treatments that benefit patients worldwide.

Key responsibilities

• Deliver site start-up and activation work to a high standard, working closely with the team and stakeholders.
• Prepare and submit regulatory documents such as clinical trial applications and ethics committee submissions.
• Coordinate with internal and external stakeholders to obtain the approvals and authorisations needed for study initiation.
• Maintain accurate and up-to-date records of regulatory submissions and approvals.
• Support study teams in developing study documents, including protocols, informed consent forms and investigator brochures.
• Take part in study start-up meetings and give input on regulatory requirements and timelines.

Required profile

• Bachelor's degree in Life Sciences or a related field.
• Demonstrated experience in 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 coordinating with sites, Ethics Committees/IRBs, Regulatory Authorities and internal study teams.
• Ability to manage multiple studies, sites, submission requirements, timelines and follow-up in a fast-paced environment.
• Willingness to work from the office 2-3 days per week.

Required skills

• Strong understanding of regulatory and documentation requirements for clinical trial start-up and site activation.
• Experience preparing, reviewing, coordinating and submitting documentation across CTF submission stages.
• Strong organisational skills, attention to detail and excellent communication and interpersonal skills.

What we offer

• 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 learning and development opportunities.