Description
Clinical Research Associates II independently monitor clinical trials, ensuring compliance with protocols, TGA regulations, and GCP guidelines. They manage multiple sites and support data quality assurance.
Responsibilities
- Conduct site initiation, monitoring, and close-out visits.
- Ensure compliance with ethical and regulatory requirements.
- Monitor patient enrolment and adherence to study protocols.
- Manage site communication and resolve issues.
- Prepare monitoring reports and updates for sponsors.
Qualifications
- Bachelor’s degree in life sciences or related field.
- 1–2 years of clinical monitoring experience in Australia.
- Strong knowledge of GCP and Australian regulations.
- Excellent organisational and problem-solving skills.
