Study Start Up Associate I

ICON; Sydney; Hybrid; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate I in Australia to help initiate clinical trials in a sponsor-dedicated model, adhering to regulatory requirements and contributing to patient-focused treatments worldwide.

You will deliver site start-up activities, assist with regulatory documents, coordinate approvals, and support study teams in creating essential documents while coordinating with internal and external stakeholders.

Qualifications

• Bachelor's degree in life sciences or a related field.
• Experience in clinical research or regulatory affairs is preferred but not required.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal abilities for cross-functional collaboration.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Willingness to travel about 5%.

Responsibilities

• Deliver site start-up and activation work to a high standard.
• Prepare and submit regulatory documents (e.g., CTA submissions).
• Coordinate with stakeholders to obtain approvals for study initiation.
• Maintain accurate records of regulatory submissions and approvals.
• Assist in development of study documents (protocols, ICFs, investigator brochures).
• Participate in start-up meetings and advise on regulatory timelines.

Skills

Attention to detail

Organizational skills

Communication

Interpersonal skills

Team collaboration

Independent work

Multitasking

Education

Bachelor's degree in life sciences or related field

Job description

SSU I, Australia - Remote or Hybrid

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%)

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values.

We're dedicated to providing an inclusive and accessible environment for all candidates.

ICON is committed to providing a workplace free of discrimination and harassment.

All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here