Clinical Research Associate II (CRA II)

Location: Adelaide or Perth (Home-Based)

Employment Type: Full time

Industry: Clinical Research / CRO

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 a broad portfolio of innovative clinical trials across multiple therapeutic areas, including Oncology.

This home-based role is ideally suited to candidates based in Adelaide or Perth and offers the opportunity to work across Phase I-III clinical studies while partnering with investigative sites and cross-functional teams to ensure successful study delivery.

The successful candidate will play a critical 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.

- Experience within Oncology and/or other therapeutic areas is highly regarded.

- Strong understanding of ICH-GCP,



regulatory requirements, and risk-based monitoring methodologies.

- Experience working within a CRO, sponsor, or FSP setting.

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.

Apply Now

If you are an experienced CRA looking to further your career in a dynamic, home-based role supporting innovative clinical research, we would love to hear from you. Join a team-oriented team committed to advancing medical innovation and improving patient outcomes across a range of therapeutic areas.

📌 Clinical Research Associate II - Australia (FSP) (Southern Sydney)
🏢 Planet Pharma
📍 Southern Sydney