Senior Clinical Research Associate

Planet Pharma; Australia; On-site; AUD 100,000 - 150,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Research Associate to lead site monitoring across Australia and New Zealand. You will own site management, monitoring activities, and study delivery while maintaining strong investigator relationships and ensuring regulatory compliance.

The role offers a hands-on SCRA path with mentorship of junior CRAs, exposure to complex global studies, and opportunities to contribute to study timelines and targets in a collaborative CRO environment.

Qualifications

• 5+ years of independent monitoring experience within Australia.
• Experience conducting all monitoring visit types across Phase II and/or III studies.
• Strong understanding of ICH-GCP and Australian regulatory requirements.
• Excellent communication and stakeholder management skills.

Responsibilities

• Conduct Site Selection, Site Initiation, Interim Monitoring, and Close-Out Visits
• Build and maintain strong relationships with investigators and site personnel
• Ensure protocol, ICH-GCP, and regulatory compliance
• Perform source data verification, CRF review, and query resolution
• Support site identification and feasibility activities
• Deliver investigator and site staff training
• Mentor and support junior CRAs
• Participate in audits and inspection-readiness activities
• Maintain study documentation and tracking systems
• Collaborate with project teams, sponsors, vendors, and regulatory stakeholders
• Drive study timelines, recruitment goals, and quality metrics

Skills

Independent monitoring

Client/stakeholder mgmt

Communication

Travel readiness

Education

Life Sciences degree

Job description

Why This Opportunity?

This is an opportunity to join a well-established, globally recognized CRO that has built a strong reputation for quality, operational excellence, and employee retention. Unlike many organizations in the market, this business is known for its collaborative culture, manageable structure, and genuine investment in its people.

The team is specifically looking for an experienced CRA who wants to build a long-term career rather than make another short-term move. You'll join an organization where performance is recognized, development is supported, and experienced CRAs are trusted to run their studies with a high degree of autonomy.

For candidates who enjoy monitoring and site engagement, this is a true hands-on SCRA role. You'll have exposure to complex global studies, strong sponsor interaction, and the opportunity to mentor junior team members while remaining close to the science and operations.

The Role

As a Senior Clinical Research Associate, you will be responsible for managing clinical trial activity across Australia and New Zealand, ensuring studies are delivered to the highest quality standards while maintaining strong relationships with investigators and study sites.

You will act as a key representative of the project team, taking ownership of site management, monitoring activities, study delivery, and stakeholder communication.

Key Responsibilities

• Conduct Site Selection, Site Initiation, Interim Monitoring, and Close-Out Visits
• Build and maintain strong relationships with investigators and site personnel
• Ensure protocol, ICH-GCP, and regulatory compliance
• Perform source data verification, CRF review, and query resolution
• Support site identification and feasibility activities
• Deliver investigator and site staff training
• Mentor and support junior CRAs
• Participate in audits and inspection-readiness activities
• Maintain study documentation and tracking systems
• Collaborate with project teams, sponsors, vendors, and regulatory stakeholders
• Drive study timelines, recruitment goals, and quality metrics

What They're Looking For

• Degree in Life Sciences, Nursing, Pharmacy, or a related discipline
• 5+ years of independent monitoring experience within Australia
• Experience conducting all monitoring visit types across Phase II and/or III studies
• Strong understanding of ICH-GCP and Australian regulatory requirements
• Excellent communication and stakeholder management skills
• Ability to work independently while contributing to a wider project team
• Willingness to travel regularly throughout Australia and occasionally New Zealand