Clinical Research Associate I/II — Remote Monitoring & Compliance

Impact Advising; Sydney; Vor Ort; AUD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Health & Wellbeing

Flexible work arrangements

Additional leave option

Charitable volunteering

Learning & development

Zusammenfassung

Thermo Fisher Scientific in Australia seeks a Clinical Research Associate (Level I/II) to perform and coordinate clinical monitoring and site management activities. You will conduct on-site or remote visits to assess protocol compliance and manage essential documentation.

The role requires knowledge of ICH-GCP, regulatory requirements and strong data integrity skills, with 60-80% travel and office-based environment.

Qualifikationen

• Bachelor's degree in life sciences or RN certification.
• 1 year of clinical research monitoring experience or completion of PPD fellowship.
• Willingness to travel 60-80% as required.
• Strong knowledge of ICH-GCP and applicable regulations.
• Ability to apply root cause analysis and problem solving.

Aufgaben

• Monitors investigator sites using a risk-based approach to identify process gaps and corrective actions.
• Ensures data accuracy through SDV/CRF review and product inventory checks.
• Documents observations in timely reports and escalates issues.
• Maintains regular contact between visits to verify protocol compliance and data capture.
• Performs monitoring tasks per the monitoring plan and participates in investigator meetings.
• Supports investigator site qualification and initiation per ICH GCP.
• Assists in trial close-out and retrieval of materials.
• Maintains essential documents per regulatory requirements and updates study systems.
• Facilitates communication among sites, client, and project team.
• Responds to audits/inspections and client requests.

Kenntnisse

Clinical monitoring

ICH GCP knowledge

Regulatory compliance

SDV/CRF review

Root cause analysis

Risk-based monitoring

Communication skills

Time management

Team collaboration

Ausbildung

Bachelor's degree life sciences

Registered Nursing certification

Tools

CTMS

Jobbeschreibung

Thermo Fisher Scientific in Australia seeks a Clinical Research Associate (Level I/II) to perform and coordinate clinical monitoring and site management activities. You will conduct on-site or remote visits to assess protocol compliance and manage essential documentation.

The role requires knowledge of ICH-GCP, regulatory requirements and strong data integrity skills, with 60-80% travel and office-based environment.