Senior Clinical Research Associate

Planet Pharma; Brisbane; On-site; AUD 90,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Research Associate to lead monitoring across Australian investigational sites. You will own a portfolio, manage site performance, and nurture investigator relationships while ensuring data integrity and regulatory compliance.

You will conduct onsite and remote monitoring across start-up to close-out, mentor junior CRAs, and collaborate with study teams to meet milestones and timelines. Domestic travel will be required.

Qualifications

• Strong independent clinical trial monitoring experience.
• Experience managing Australian clinical trial sites with minimal supervision.
• Ability to manage sites across multiple stages of the clinical trial lifecycle.
• Strong knowledge of ICH-GCP and clinical research quality requirements.
• Confidence managing investigator and site relationships.
• Experience identifying, escalating and resolving site performance or compliance issues.
• Strong organisational skills with the ability to manage multiple sites and competing priorities.
• Excellent communication and stakeholder management skills.

Responsibilities

• Independently manage investigational sites throughout the clinical trial lifecycle.
• Conduct onsite and remote monitoring activities across start-up, initiation, active recruitment and close-out.
• Build strong working relationships with investigators and site teams.
• Monitor site quality, protocol compliance, patient safety and data integrity.
• Review source documentation and support the timely resolution of data and site-level issues.
• Monitor patient recruitment and site performance, identifying issues and supporting appropriate improvement plans.
• Ensure essential study and regulatory documentation is complete, accurate and inspection-ready.
• Oversee investigational product accountability and associated study materials.
• Identify potential risks early and work with internal teams and sites to implement appropriate corrective actions.
• Partner with Clinical Project Managers and wider study teams to ensure milestones and timelines are achieved.
• Provide clear updates on site progress, risks and performance to internal and external stakeholders.
• Support less experienced CRAs through mentoring and knowledge sharing.
• Depending on experience, take on additional responsibilities across study leadership and CRA oversight.

Skills

Independent monitoring

Site management

Stakeholder management

ICH-GCP knowledge

Investigator relationships

Issue escalation

Multi-site coordination

Communication

Life sciences background

Domestic travel

Education

Background in life sciences, nursing, pharmacy, health sciences or clinical research

Job description

The Opportunity

We are supporting an international clinical research organisation looking to strengthen its Australian clinical operations team with an experienced Senior Clinical Research Associate.

The role will suit an established CRA who is confident managing Australian investigational sites independently and wants to take greater ownership across study delivery, site performance and stakeholder relationships.

Brisbane is the priority location, although experienced candidates elsewhere in Australia may be considered where they are comfortable travelling.

There is an active hiring need, with candidates who are immediately available or on a short notice period particularly encouraged to apply.

The Role

As a Senior CRA, you will take ownership of an assigned portfolio of clinical trial sites and act as a key link between investigators, study teams and sponsors.

Responsibilities will include:

• Independently manage investigational sites throughout the clinical trial lifecycle.
• Conduct onsite and remote monitoring activities across start-up, initiation, active recruitment and close-out.
• Build strong working relationships with investigators and site teams.
• Monitor site quality, protocol compliance, patient safety and data integrity.
• Review source documentation and support the timely resolution of data and site-level issues.
• Monitor patient recruitment and site performance, identifying issues and supporting appropriate improvement plans.
• Ensure essential study and regulatory documentation is complete, accurate and inspection-ready.
• Oversee investigational product accountability and associated study materials.
• Identify potential risks early and work with internal teams and sites to implement appropriate corrective actions.
• Partner with Clinical Project Managers and wider study teams to ensure milestones and timelines are achieved.
• Provide clear updates on site progress, risks and performance to internal and external stakeholders.
• Support less experienced CRAs through mentoring and knowledge sharing.
• Depending on experience, take on additional responsibilities across study leadership and CRA oversight.

What We’re Looking For

We are interested in experienced CRAs who can demonstrate:

• Strong independent clinical trial monitoring experience.
• Experience managing Australian clinical trial sites with minimal supervision.
• Ability to manage sites across multiple stages of the clinical trial lifecycle.
• Strong knowledge of ICH-GCP and clinical research quality requirements.
• Confidence managing investigator and site relationships.
• Experience identifying, escalating and resolving site performance or compliance issues.
• Strong organisational skills with the ability to manage multiple sites and competing priorities.
• Excellent communication and stakeholder management skills.
• A relevant background in life sciences, nursing, pharmacy, health sciences or clinical research.
• Full Australian working rights, as visa sponsorship is not available.
• Ability to travel domestically as required.