Overview
Coordinate and manage clinical monitoring activities across all trial phases and therapeutic areas
Full service CRO with in-house regulatory affairs consultancy
Sydney-based role with multiple positions available across NSW
Benefits
Work for a leading CRO across Asia-Pacific
Regular training and international knowledge-sharing opportunities
Get exposure to a diverse range of therapeutic areas
About the prospect
Acting as the primary link between the sites and the sponsor, the CRA will coordinate and manage clinical monitoring activities from site start-up through to close out.
Duties
Prepare, organise, conduct and follow-up routine monitoring and close out visits as per relevant study plan
Motivate and train investigators and site staff to ensure obligations in regard to study timelines
Ensure compliance with ICH/GCP, study protocols and other applicable regulatory guidelines
Oversee all ethics submissions and trial reporting
Follow company SOP's and adapt knowledge and processes as applicable to the therapeutic area
Contribute to process improvements and protocol review
Minimum requirements
Tertiary degree in life sciences or relevant subject
Minimum 12 months independent monitoring experience with a strong track record of performing site visits according to the Clinical Monitoring Plan
Experience working in a CRO setting
Oncology monitoring experience highly regarded
Solid knowledge of GCP and national and international regulations, with a sound understanding of how they apply to your role
Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
Full Australian working rights
Culture
Fast paced and adaptable CRO that sets a high benchmark for clinical trial operations across the Asia-Pacific.
Join an inclusive, collegiate team that places a robust emphasis on supporting its people and valuing their contribution to organisational and client success.
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📌 Clinical Research Associate New South Wales
🏢 Healthcare Professionals Group
📍 New South Wales
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