Study Start Up Associate I

ICON Strategic Solutions (FSP); Sydney; Presencial; AUD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Flexible benefits

Descripción de la vacante

ICON Strategic Solutions (FSP) – Sydney NSW is seeking a Study Start Up Associate I to facilitate trial initiation, ensuring regulatory compliance and timely study activation across sites. You will deliver site start-up and activation work, coordinate with cross-functional teams, and prepare regulatory documents such as regulatory submissions and ethics approvals.

Travel up to 5% may be required. Ideal candidates possess a life sciences degree, strong attention to detail, and ability to manage

Formación

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

Responsabilidades

• Deliver site start-up and activation work to a high standard, coordinating with team and stakeholders.
• Assist in preparation and submission of regulatory documents (clinical trial applications, ethics submissions).
• Coordinate with internal/external stakeholders for approvals and authorizations for study initiation.
• Maintain accurate records of regulatory submissions and approvals.
• Support development of study documents (protocols, informed consent forms, investigator brochures).
• Participate in start-up meetings and advise on regulatory requirements and timelines.

Conocimientos

Attention to detail

Communication skills

Time management

Independent worker

Travel willingness

Educación

Bachelor's degree in life sciences

Descripción del empleo

ICON Strategic Solutions (FSP) – Sydney NSW

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.

• 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.

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