Home-Based CRA II for Immunology Trials (Phase I-III)

Planet Pharma; Gisborne; On-site; AUD 90,000 - 120,000; Full time

Job summary

Planet Pharma seeks an experienced Clinical Research Associate II for a home-based role on the East Coast of Australia. You will oversee monitoring activities across Phase I–III trials, partnering with investigative sites and cross-functional teams to ensure safety, data integrity and regulatory compliance.

You will maintain inspection readiness, manage ISF/TMF, and collaborate with study personnel to meet timelines.

Qualifications

• Bachelor's degree in Life Sciences or related discipline.
• Significant on-site monitoring experience in Phase I–III.
• Strong knowledge of ICH-GCP and risk-based monitoring.
• Experience in CRO/sponsor/FSP environments.

Responsibilities

• Conduct on-site and remote monitoring visits (SQV, SIV, IMV, COV).
• Ensure compliance with ICH-GCP, study protocols, regulatory requirements and SOPs.
• Verify informed consent procedures and data integrity.
• Maintain site readiness and ISF/TMF quality.
• Build relationships with investigators and site staff; support recruitment/engagement.

Skills

Communication

Stakeholder management

Negotiation

Detail oriented

Organizational skills

Independent work

Cross-functional collaboration

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Tools

Microsoft Office

Job description

Planet Pharma seeks an experienced Clinical Research Associate II for a home-based role on the East Coast of Australia. You will oversee monitoring activities across Phase I–III trials, partnering with investigative sites and cross-functional teams to ensure safety, data integrity and regulatory compliance.

You will maintain inspection readiness, manage ISF/TMF, and collaborate with study personnel to meet timelines.