Job Description
The client is preparing the launch of an international randomized clinical trial (RCT) across Europe and the United States to support marketing authorization. Due to the absence of a full CRO model, key activities will be managed internally. We are therefore seeking experienced Senior CRAs to support site selection and regulatory submissions.
n
Scope of the mission
n
n
Site selection (including on-site visits if required)
n
Support to site onboarding and informed consent preparation
n
Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities)
n
Adaptation of documents to local requirements and translation coordination
n
Country-specific regulatory guidance
n
n
Profile requirements
n
n
Senior CRA with solid autonomy
n
Experience in site selection and submissions
n
Knowledge of local regulatory requirements
n
Late-stage study experience (phase II, III)
n
Solid understanding of country-specific regulatory frameworks
n
Local language may be required depending on country
n
#J-*****-Ljbffr

📌 Senior Clinical Research Associate (New South Wales)
🏢 ARTO
📍 New South Wales