CLINICAL RESEARCH ASSOCIATE II – AUSTRALIA (FSP)
Planet PharmaClinical Research Associate II – Australia (FSP)
Location: Remote - East Coast Australia, New South Wales
Category: Clinical Development and Operations
Salary: Apply for details
Country: Australia
Employment: Direct Hire/Perm
Worksite: On-Site
Apply For This Position
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
To be considered for this opportunity, applicants must have unrestricted working rights in Australia:
If you are an experienced CRA looking for an opportunity to work on cutting-edge clinical research programs while enjoying the flexibility of a home-based role, we’d love to hear from you. Join a collaborative team dedicated to advancing medical innovation and improving patient outcomes.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Location: Remote - East Coast Australia, New South Wales
Category: Clinical Development and Operations
Salary: Apply for details
Country: Australia
Employment: Direct Hire/Perm
Worksite: On-Site
Apply For This Position
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.
- 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.
- 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 for an opportunity to work on cutting-edge clinical research programs while enjoying the flexibility of a home-based role, we’d love to hear from you. Join a collaborative team dedicated to advancing medical innovation and improving patient outcomes.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.