Study Start-Up Associate I: Regulatory Coordination (PT)

Aurion; Australia; Hybrid; AUD 70,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning opportunities

Employee assistance program LifeWorks

Life assurance

Childcare vouchers / family benefits

Job summary

ICON Strategic Solutions Australia is seeking a Study Start Up Associate I to support site start-up and activation for clinical trials in a sponsor-dedicated model. You will work with a global team to ensure regulatory compliance and timely study activation.

You will prepare regulatory documents, coordinate approvals, maintain records, and assist in developing study documents, with travel up to 5%. The role offers stability, development and a collaborative environment across the organization.

Qualifications

• Bachelor's degree in life sciences or related field.
• Clinical research or regulatory affairs experience preferred.
• Strong attention to detail and organisational skills.
• Excellent communication and cross-functional collaboration.
• 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.
• Coordinate with internal and external stakeholders for approvals.
• Assist in preparation and submission of regulatory documents.
• Maintain accurate records of regulatory submissions and approvals.
• Support study teams in development of study documents.
• Participate in start-up meetings and advise on regulatory timelines.

Skills

Attention to detail

Organisational skills

Communication skills

Interpersonal skills

Cross-functional collaboration

Independent work

Travel willingness

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions Australia is seeking a Study Start Up Associate I to support site start-up and activation for clinical trials in a sponsor-dedicated model. You will work with a global team to ensure regulatory compliance and timely study activation.

You will prepare regulatory documents, coordinate approvals, maintain records, and assist in developing study documents, with travel up to 5%. The role offers stability, development and a collaborative environment across the organization.