Study Start Up Associate I

About the role

ICON Strategic Solutions is hiring a Study Start Up Associate I in Australia, working remotely or hybrid in a sponsor-dedicated model. The role supports the initiation of clinical trials, ensuring compliance with regulatory requirements and helping develop 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.
• Assist in preparing and submitting 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.
• Previous experience in clinical research or regulatory affairs preferred but not required.
• Willingness to travel as required (about 5%).
• Legal right to work in the country where the role is based.

Required skills

• Strong attention to detail and organisational skills.
• Excellent communication and interpersonal skills, able to collaborate across functions.
• Ability to work independently and manage several tasks at once in a fast-paced environment.

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 wellbeing resources.
• Learning and development opportunities through structured training and career pathways.