Site Navigator II (Regulatory & Start up Specialist) - FSP

Fortrea

Sydney

3 days ago

Sydney

3 days ago

Apply

Site Navigator II (Regulatory & Start up Specialist) - FSP

Site Navigator II coordinates site-level activities for clinical study start-up, ensuring regulatory compliance and site activation. Requires 2+ years clinical development experience and knowledge of ICH/GCP guidelines. Remote-based role in Sydney, Australia.

Apply

Remote

Full-time

Mid Level

ICH/GCP Guidelines

Regulatory Affairs

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

Remote-based work required with possible office presence depending on location

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/GCP guidelinesRegulatory AffairsIRB/IEC regulationsClinical research protocolsTrial Master FileInformed Consent FormCase Report FormSerious Adverse Event reportingData validation

Soft Skills

CommunicationTime managementProblem solvingNegotiationCollaborationAttention to detailMentoringOrganizational skills

Key Responsibilities

•Oversight of site level tasks for efficient site activation
•Identify potential research sites and assess capabilities
•Conduct initial site outreach, collection of Confidentiality Agreement, and feasibility survey
•Remote Pre-Study Visits and follow up documentation
•Support customization and translation of informed consent forms
•Collect, track and perform quality review of essential documents
•Actively participate in team meetings to facilitate study progress
•Support CRA team in preparing for site initiation visits
•Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities
•Perform initial contract and budget negotiations with sites
•Ensure high quality documents filed in applicable systems
•Track progress of start-up process and ensure site meets requirements
•Ensure Fortrea is audit ready by completing system compliance
•Serve as primary contact for investigative sites
•Perform CRF review and data validation against source documentation
•Perform country and site ICF review/customization

Clinical ResearchSite ActivationRegulatoryStart-upICH/GCPRemoteAustraliaCROFSP

Core Qualifications

Technical (Must-have)

ICH/GCP guidelinesRegulatory AffairsIRB/IEC regulationsClinical research protocolsTrial Master FileInformed Consent FormCase Report FormSerious Adverse Event reportingData validation

Soft Skills

CommunicationTime managementProblem solvingNegotiationCollaborationAttention to detailMentoringOrganizational skills

Key Responsibilities

•Oversight of site level tasks for efficient site activation

•Identify potential research sites and assess capabilities

•Conduct initial site outreach, collection of Confidentiality Agreement, and feasibility survey

•Remote Pre-Study Visits and follow up documentation

•Support customization and translation of informed consent forms

•Collect, track and perform quality review of essential documents

•Actively participate in team meetings to facilitate study progress

•Support CRA team in preparing for site initiation visits

•Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities

•Perform initial contract and budget negotiations with sites

•Ensure high quality documents filed in applicable systems

•Track progress of start-up process and ensure site meets requirements

•Ensure Fortrea is audit ready by completing system compliance

•Serve as primary contact for investigative sites

•Perform CRF review and data validation against source documentation

•Perform country and site ICF review/customization