Clinical Trial Start-Up Associate I

ICON Strategic Solutions (FSP); Sydney; On-site; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Flexible benefits

Job summary

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

Qualifications

• 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%.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

Time management

Independent worker

Travel willingness

Education

Bachelor's degree in life sciences

Job description

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