Study Start Up Associate I

ICON Clinical Research; Sydney; On-site; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Health and wellbeing programmes

Retirement and pension plans

Life assurance

Learning and development opportunities

Job summary

ICON Strategic Solutions in Sydney, Australia seeks a Study Start Up Associate I to drive site initiation and regulatory submission activities. You will work with cross-functional teams to ensure compliance and timely study activation.

Applicants should have a life sciences degree and strong attention to detail, with excellent communication skills and the ability to manage multiple tasks in a fast-paced clinical research environment.

Qualifications

• Bachelor's degree in life sciences or a related field.

Responsibilities

• Assist in regulatory documents preparation and submission (e.g., CTAs and ethics submissions).
• Co-ordinate with internal and external stakeholders for study initiation
• Maintain accurate records of regulatory submissions and approvals
• Support study teams in development of study documents (protocols, informed consent forms, investigator brochures)
• Participate in study start-up meetings and advise on regulatory timelines

Skills

Attention to detail

Communication skills

Organization

Stakeholder collaboration

Independent work

Education

Bachelor's degree in life sciences or related field

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Study Start Up Associate I at ICON, you will facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

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:

• Assisting in the 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.
• Previous experience in clinical research or regulatory affairs preferred, but Nt 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%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

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

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a requesthere.