Clinical Research Associate II - Australia (FSP)
- Hiring from
- Australia, Costa Rica
- Work type
- Remote
- Posted
- Oct 1, 2026
Is this job info correct?
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
To be considered for this opportunity, applicants must have unrestricted working rights in Australia:
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 collaborative team committed to advancing medical innovation and improving patient outcomes across a range of therapeutic areas.
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.
- 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 environment.
- 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.
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related discipline; or
- An equivalent combination of education and relevant clinical research experience.
- Comfortable with regular interstate travel.
- Domestic travel of up to 60% is required.
To be considered for this opportunity, applicants must have unrestricted working rights in Australia:
- Australian Citizen; or
- Australian Permanent Resident.
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 collaborative team committed to advancing medical innovation and improving patient outcomes across a range of therapeutic areas.