Remote Study Start-Up Specialist – Site Activation

Engineering Design & Consulting; Brisbane; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Site Activation Partner - FSP (Study Start-Up Associate) to coordinate site activation and regulatory submissions for global clinical trials in Australia and beyond.

You will manage essential documents, support IRB/ethics approvals, maintain TMF accuracy, and liaise with investigators and cross-functional teams to ensure on-time site initiation and study conduct, with occasional international travel and a remote-work arrangement.

Qualifications

• Minimum 2 years of experience in clinical site activation.
• Fluent in English; local language knowledge preferred.
• Knowledge of ICH-GCP and regulatory requirements.
• Experience with TMF and regulatory submissions.
• Willingness to travel internationally.

Responsibilities

• Coordinate site activation activities and essential documents.
• Support regulatory submissions and ethics/IRB approvals.
• Maintain TMF documents and study files.
• Communicate with sites and study team to resolve issues.
• Assist with audits and inspections.
• Act as SME for site activation processes.

Skills

Clinical trials

GCP compliance

Regulatory submissions

TMF management

CTMS

Florence

SIP

Documentation

Travel readiness

Education

Bachelor's degree in life sciences

Tools

CTMS

Florence

Shared Investigator Platform

TMF system

Job description

Parexel is seeking a Site Activation Partner - FSP (Study Start-Up Associate) to coordinate site activation and regulatory submissions for global clinical trials in Australia and beyond.

You will manage essential documents, support IRB/ethics approvals, maintain TMF accuracy, and liaise with investigators and cross-functional teams to ensure on-time site initiation and study conduct, with occasional international travel and a remote-work arrangement.