Remote Clinical Trials Site Activation Associate

Csea; Australia; Remote; AUD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Site Activation Partner - FSP (Study Start-Up Associate) for a fixed-term contractor role through April 2027. The position allows full remote work and involves coordinating site activation activities, regulatory submissions, and life-cycle study documentation across multiple countries.

Key responsibilities include preparing IIP submissions, IRB interactions, TMF updates, and ensuring timely communication with investigators and study teams.

Qualifications

• Experience with site activation and regulatory submissions.
• Ability to coordinate with IRB/ethics committees and regulatory bodies.
• Strong cross-functional collaboration across study teams.

Responsibilities

• Initiate and coordinate site activation activities and essential documents.
• Manage regulatory submissions (IRB/ethics approvals, FDA forms) within required timelines.
• Coordinate with cross-functional teams to ensure site readiness and study compliance.
• Maintain TMF documentation and study records accuracy.

Skills

Site activation

Regulatory submissions

IRB/Ethics coordination

Cross-functional coordination

SIP platform

Tools

Shared Investigator Platform (SIP)

Trial Master File (TMF) systems

Job description

Parexel is seeking a Site Activation Partner - FSP (Study Start-Up Associate) for a fixed-term contractor role through April 2027. The position allows full remote work and involves coordinating site activation activities, regulatory submissions, and life-cycle study documentation across multiple countries.

Key responsibilities include preparing IIP submissions, IRB interactions, TMF updates, and ensuring timely communication with investigators and study teams.