Study Start Up Associate I
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Job Description
Study Start Up Associate facilitating Australian clinical trial site activation for ICON. Preparing regulatory submissions and coordinating approvals for sponsor-dedicated clinical trials.
Responsibilities:
- Facilitate the initiation of clinical trials and ensure compliance with regulatory requirements
- Deliver site start-up and activation work to a high standard
- Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
- Maintain accurate and up-to-date records of regulatory submissions and approvals
- Support study teams in developing protocols, informed consent forms, and investigator brochures
- Participate in study start-up meetings and provide input on regulatory requirements and timelines
Requirements:
- Bachelor's degree in life sciences or a related field
- Previous experience in clinical research or regulatory affairs preferred, but not required
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
- Willingness to travel as required (approximately 5%)
- Legal right to work in the country where the role is based
Benefits:
- 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
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