Study Start-Up Associate I — Remote/Hybrid Clinical Trials

KCR Placement; Sydney; Hybrid; AUD 70.000 - 100.000; Vollzeit

Benefits dieser Stelle

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Zusammenfassung

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.

Qualifikationen

• 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%.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Organizational skills

Communication

Interpersonal skills

Team collaboration

Independent work

Multitasking

Ausbildung

Bachelor's degree in life sciences or related field

Jobbeschreibung

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.