Study Start-Up Associate I — Remote/Hybrid

ALRA | Australia's Leading Recruitment Agency; Canberra; Hybrid; AUD 70.000 - 90.000; Vollzeit

Benefits dieser Stelle

Annual leave entitlements

Health insurance

Retirement planning

Zusammenfassung

ICON Strategic Solutions is seeking a Study Start Up Associate I to drive site start-up and activation for clinical trials. You will prepare regulatory documents, coordinate approvals, and maintain submission records while supporting study teams in protocol and document development.

The role emphasizes collaboration with stakeholders, regulatory compliance, and timely study initiation, with a flexible remote/hybrid setup in Australia.

Qualifikationen

• Bachelor's degree in life sciences or related field.
• Clinical research or regulatory affairs experience preferred but not required.
• Strong attention to detail and organisational skills.
• Excellent communication and interpersonal abilities for cross-functional collaboration.

Aufgaben

• Deliver site start-up and activation work to a high standard.
• Assist in preparation and submission of regulatory documents (CTAs, ethics submissions).
• Coordinate with internal/external stakeholders for approvals and study initiation.
• Maintain accurate regulatory submissions records and approvals.
• Support study teams in developing study documents (protocols, ICFs, investigator brochures).
• Participate in start-up meetings and provide input on regulatory requirements and timelines.

Kenntnisse

Attention to detail

Communication skills

Team collaboration

Independent multitasking

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

ICON Strategic Solutions is seeking a Study Start Up Associate I to drive site start-up and activation for clinical trials. You will prepare regulatory documents, coordinate approvals, and maintain submission records while supporting study teams in protocol and document development.

The role emphasizes collaboration with stakeholders, regulatory compliance, and timely study initiation, with a flexible remote/hybrid setup in Australia.