Site Navigator II (Site Activation Specialist)

Fortrea

Sydney

2 days ago

Sydney

2 days ago

Apply

Site Navigator II (Site Activation Specialist)

The Site Navigator II (Site Activation Specialist) coordinates site-level activities for clinical study start-up, ensuring regulatory compliance and smooth activation. The role is based in Sydney, Australia, requires experience in clinical research, and offers a full-time, on-site position.

Apply

On-site

Full-time

Mid Level

ICH/GCP

SOPs

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

On-site

Experience Required

2 years

Employment Type

Full-time

Experience Level

Minimum 2 years in clinical development or start-up/regulatory process

Core Qualifications

Technical (Must-have)

ICH/GCPSOPsIRB/IEC regulationsRegulatory AffairsInformed Consent FormsTrial Master FileCase Report Form reviewSource document verificationClinical trial managementContract negotiations

Soft Skills

CommunicationCollaborationProblem solvingTime managementMentoringAttention to detailNegotiationMultitasking

Key Responsibilities

•Oversee site-level tasks for efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements.
•Identify potential research sites and assess their capabilities and resources.
•Conduct initial site outreach including site engagement, Confidentiality Agreement collection, and feasibility survey.
•Perform remote Pre-Study Visits and follow up documentation.
•Support customization and translation of informed consent forms and patient-facing materials.
•Collect, track and quality review essential documents for site activation and maintain regulatory compliance.
•Actively participate in team meetings to facilitate study progress and implement action plans.
•Support CRA team in preparing for site initiation visits by coordinating with vendors and supplies teams.
•Liaise with IRB/IEC, Third Bodies, and Regulatory Authorities.
•Perform initial contract and budget negotiations with sites.
•Ensure Trial Master File is updated and audit ready.
•Track progress of start-up process and ensure sites meet requirements and deadlines.
•Serve as primary contact for investigative sites.
•Perform Case Report Form review and data validation against source documentation.
•Perform country and site ICF review/customization per local requirements.

Clinical ResearchSite ActivationStart-upRegulatory ComplianceICH/GCPCROBiotechnologyFull-timeSydneyOn-site

Core Qualifications

Technical (Must-have)

ICH/GCPSOPsIRB/IEC regulationsRegulatory AffairsInformed Consent FormsTrial Master FileCase Report Form reviewSource document verificationClinical trial managementContract negotiations

Soft Skills

CommunicationCollaborationProblem solvingTime managementMentoringAttention to detailNegotiationMultitasking

Key Responsibilities

•Oversee site-level tasks for efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements.

•Identify potential research sites and assess their capabilities and resources.

•Conduct initial site outreach including site engagement, Confidentiality Agreement collection, and feasibility survey.

•Perform remote Pre-Study Visits and follow up documentation.

•Support customization and translation of informed consent forms and patient-facing materials.

•Collect, track and quality review essential documents for site activation and maintain regulatory compliance.

•Actively participate in team meetings to facilitate study progress and implement action plans.

•Support CRA team in preparing for site initiation visits by coordinating with vendors and supplies teams.

•Liaise with IRB/IEC, Third Bodies, and Regulatory Authorities.

•Perform initial contract and budget negotiations with sites.

•Ensure Trial Master File is updated and audit ready.

•Track progress of start-up process and ensure sites meet requirements and deadlines.

•Serve as primary contact for investigative sites.

•Perform Case Report Form review and data validation against source documentation.

•Perform country and site ICF review/customization per local requirements.