Clinical Research Associate II – Australia (FSP)

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

Clinical Research Associate II (CRA II)

Location: East Coast Australia (Home-Based)
Employment Type: Full-Time
Industry: Clinical Research / CRO
Travel Requirement: Up to 60% Domestic Travel

About the Opportunity

An exciting opportunity is available for an experienced Clinical Research Associate II to join a dedicated Functional Service Provider (FSP) team supporting innovative clinical development programs within Immunology and Early Development.

This home-based role offers the opportunity to work across Phase I-III clinical trials, partnering with investigative sites and cross-functional teams to ensure the successful delivery of clinical research studies. The successful candidate will play a key role in maintaining participant safety, data integrity, regulatory compliance, and overall site performance throughout the clinical trial lifecycle.

Key Responsibilities

• Conduct onsite and remote monitoring activities, including:

  • Site Qualification Visits (SQV)
  • Site Initiation Visits (SIV)
  • Interim Monitoring Visits (IMV)
  • Close-Out Visits (COV)

• Perform monitoring activities in accordance with ICH-GCP, study protocols, regulatory requirements, and applicable SOPs.

• Verify informed consent procedures and ensure protocol adherence to protect participant safety and study integrity.

• Review source documentation and ensure data accuracy, completeness, and consistency within clinical systems.

• Maintain a high level of inspection readiness across assigned sites.

• Manage Investigator Site Files (ISF) and support Trial Master File (TMF) completeness and quality.

• Build and maintain strong working relationships with investigators, study coordinators, and site personnel.

• Support site recruitment, retention, and engagement activities to meet study objectives.

• Ensure timely reporting and documentation of serious adverse events, protocol deviations, and other safety-related information.

• Oversee investigational product accountability, storage, and documentation in accordance with study requirements.

• Proactively identify site risks and drive issue resolution through corrective and preventive actions (CAPAs).

• Support regulatory inspections, sponsor audits, and follow-up activities.

• Contribute to feasibility assessments, site selection, and ethics submissions as required.

• Collaborate closely with project teams to ensure quality delivery within study timelines.

• Effectively utilise approved technologies and digital platforms to support efficient clinical trial execution.

Required Experience

• Significant independent on-site monitoring experience across Phase I-III clinical trials.
• Proven track record of managing investigative sites autonomously through the full clinical trial lifecycle.
• Experience conducting qualification, initiation, routine monitoring, and close-out visits.
• Strong understanding of ICH-GCP, regulatory requirements, and risk-based monitoring methodologies.
• Experience working within a CRO, sponsor, or FSP environment.
• Therapeutic experience in Immunology, Early Development, or related areas will be highly regarded.

Skills & Competencies

• Excellent verbal and written communication skills.
• Strong interpersonal and stakeholder management capabilities.
• Effective negotiation and problem-solving skills.
• High attention to detail and commitment to quality.
• Strong organisational, planning, and prioritisation skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Outlook.
• Comfortable working with clinical trial technologies and digital platforms.
• Commitment to maintaining confidentiality, compliance, and data integrity.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, Nursing, or a related discipline; or
• An equivalent combination of education and relevant clinical research experience.

Travel Requirements

• Comfortable with regular interstate travel.
• Domestic travel of up to 60% is required.

Eligibility

To be considered for this opportunity, applicants must have unrestricted working rights in Australia:

• Australian Citizen; or
• Australian Permanent Resident.