Lead Clinical Research Associate - Hybrid Sydney

CTI Clinical Trial and Consulting Services; Sydney; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

CTI Clinical Trial and Consulting Services seeks a Clinical Research Associate (CRA) in Sydney. The role entails site monitoring across PSV, SIV, IMV, and COV, with responsibilities from site start-up to close-out.

You will manage regulatory documents, train team members, and support investigator and sponsor communications. The ideal candidate has at least 3 years of clinical trial monitoring experience, a relevant degree (or RN/ADN equivalents), and eligibility to work in Australia.

Qualifications

• Minimum 3 years' clinical trial monitoring experience or equivalent.

Responsibilities

• Serve as main CTI contact for assigned study sites.
• Conduct site visits (PSV/SIV/IMV/COV) with quality and timelines.
• Assist with feasibility, pre-study activities and site selection.
• Collect, review and track essential/regulatory documents.
• Coordinate training and participate in team meetings; may present.
• Create and implement subject enrollment strategies for sites.
• Ensure proper storage, dispensation and accountability of Investigational Product.
• Provide updates to Clinical Project Manager; monitor remotely per plan.
• Contribute to CRFs and study documents; translate/review Patient Information sheets.

Skills

Clinical trial monitoring

Education

Bachelor's degree or higher in allied health or RN with ADN or 3-year Nursing Diploma

Job description

CTI Clinical Trial and Consulting Services seeks a Clinical Research Associate (CRA) in Sydney. The role entails site monitoring across PSV, SIV, IMV, and COV, with responsibilities from site start-up to close-out.

You will manage regulatory documents, train team members, and support investigator and sponsor communications. The ideal candidate has at least 3 years of clinical trial monitoring experience, a relevant degree (or RN/ADN equivalents), and eligibility to work in Australia.