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 opportunity

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 environment
- 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 cutting-edge 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 strong emphasis on supporting its people and valuing their contribution to organisational and client success.

#J-18808-Ljbffr

📌 Clinical Research Associate (City of Sydney)
🏢 Healthcare Professionals Group
📍 City of Sydney