Site Navigator I (Site Activation/IHCRA)

Fortrea

Sydney

2 days ago

Sydney

2 days ago

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Site Navigator I (Site Activation/IHCRA)

Site Navigator I coordinates site-level activities during clinical study start-up, serving as the primary contact for investigative sites. This role requires compliance with ICH/GCP guidelines, regulatory submissions, and contract negotiations. Candidates need a university degree or equivalent clinical research experience.

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Remote

Full-time

Entry Level

ICH/GCP

Regulatory Affairs

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

Remote

Experience Required

2 years

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Technical (Must-have)

ICH/GCPRegulatory AffairsIRB/IECClinical ResearchTrial Master FileCase Report FormSource DocumentationSerious Adverse Event ReportingInformed Consent Form

Soft Skills

CommunicationProblem SolvingNegotiationTime ManagementOrganizational SkillsAttention to Detail

Key Responsibilities

•Oversee site-level tasks for efficient site activation in compliance with ICH/GCP, local regulations, SOPs, and project requirements.
•Identify potential research sites and assess their capabilities and resources.
•Conduct initial site outreach including engagement, collection of Confidentiality Agreement, and feasibility survey.
•Apply independent judgment in managing site-level activities and resolving issues.
•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.
•Participate in study team meetings and develop action plans for site-level risks.
•Support CRA team in preparing for site initiation visits.
•Responsible for submissions to IRB/IEC, Third Bodies, and Regulatory Authorities.
•Perform initial contract and budget negotiations with sites.
•Ensure high-quality documents are filed in applicable systems and Trial Master File is audit-ready.
•Track progress of start-up process and ensure site meets requirements.
•Ensure Fortrea is audit ready through 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 per local requirements.

Site NavigatorClinical ResearchSite ActivationICH/GCPRegulatory AffairsStart-upCROSponsorRemote

Key Responsibilities

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

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

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

•Apply independent judgment in managing site-level activities and resolving issues.

•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.

•Participate in study team meetings and develop action plans for site-level risks.

•Support CRA team in preparing for site initiation visits.

•Responsible for submissions to IRB/IEC, Third Bodies, and Regulatory Authorities.

•Perform initial contract and budget negotiations with sites.

•Ensure high-quality documents are filed in applicable systems and Trial Master File is audit-ready.

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

•Ensure Fortrea is audit ready through 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 per local requirements.