About the company
Join a well-established Australian CRO with a strong APAC footprint, delivering trials across multiple therapeutic areas and all phases. You'll be part of a close-knit team that values your input and invests in your development.
About the opportunity
As a Senior CRA, you'll be central to delivering high-quality clinical trials, keeping studies safe, ethical and efficient while building lasting partnerships across sites and sponsors.
Duties
- FSP model
- Conduct site selection, initiation, interim monitoring and close-out visits
- Develop and drive patient recruitment plans with sites
- Train and support site staff on study protocols and materials
- Perform data checks in line with the Clinical Monitoring Plan
- Resolve site issues promptly and elevate where needed
- Follow up on quality issues as they arise
- Prepare and finalise monitoring visit reports
- Collect and upload essential documents to the eTMF on time
- Support investigator selection and feasibility activities
- Prepare sites for audits and regulatory inspections
Skills and Experience
- Bachelor's degree in a scientific discipline or health care is preferred
- Previous experience as a Senior CRA
- Minimum of 4 years of independent monitoring experience
- Excellent knowledge of ICH-GCP guidelines and local regulations
- Understanding of the drug development process
- Strong written, verbal, and computer skills
- Ability to work independently in remote environments
Culture
You'll join a collaborative, high-performing team where ownership is encouraged, ideas are heard and your work makes a real difference to clinical research across Asia-Pacific.
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Senior Clinical Research Associate in Sydney employer: Healthcare Professionals Group
Join a leading Australian business in the therapeutic goods sector, where you will play a pivotal role as a Regulatory and Quality Manager. This position offers a collaborative work culture that values innovation and continuous improvement, providing ample opportunities for professional growth and development. With a focus on shaping compliance frameworks and engaging with both local and international suppliers, you'll find a rewarding environment that encourages meaningful contributions to the healthcare landscape.
Contact Details:
Healthcare Professionals Group Recruitment Team
