Senior Clinical Research Associate (Adelaide) – Remote/Hybrid

Emerald Clinical Trials Inc.; Adelaide; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Hybrid or remote work

Career growth

Employee wellbeing

Global opportunities

Job summary

Emerald Clinical Trials is seeking a Clinical Research Associate 2 to join the Clinical Operations group. You will be responsible for site management, monitoring tasks, and providing operational support to multicenter trials across phases I-IV.

The role requires tertiary qualifications in a related science, with more than 2 years' on-site monitoring experience. Travel may be required, and familiarity with ICH-GCP and regulatory requirements is essential.

Qualifications

• More than 2 years' on-site monitoring and site management experience is mandatory.
• Experience in renal and/or oncology trials is a plus.
• Knowledge of ICH-GCP guidelines and global/regulatory requirements.
• Ability to travel as required.

Responsibilities

• Identify investigators and sites for trial feasibility and selection.
• Conduct monitoring activities per Monitoring Plan and prepare visit reports.
• Plan and conduct site evaluation visits and report findings.
• Coordinate regulatory packages and ethics submissions with colleagues.
• Negotiate site budgets and oversee contract execution and payments.
• Plan and conduct site initiation visits.
• Develop monitoring tools and TMF-related documents.
• Train investigators on protocol, product, and trial requirements.
• Reconcile TMF contents with site files.
• Coordinate distribution and handling of investigational products and trial supplies.
• Maintain trial data in CTMS and other reporting tools.
• Support strategies to boost recruitment.

Skills

Negotiation

Critical thinking

Problem solving

Decision making

Strategic thinking

Interpersonal communication

Presentation skills

Flexibility

Travel willingness

ICH-GCP knowledge

Education

Tertiary qualification in science/healthcare

Job description

Emerald Clinical Trials is seeking a Clinical Research Associate 2 to join the Clinical Operations group. You will be responsible for site management, monitoring tasks, and providing operational support to multicenter trials across phases I-IV.

The role requires tertiary qualifications in a related science, with more than 2 years' on-site monitoring experience. Travel may be required, and familiarity with ICH-GCP and regulatory requirements is essential.