Clinical Research Associate II (FSP) - Sydney

FTSYD Fortrea Australia Pty Ltd; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Fortrea Australia Pty Ltd is seeking a Clinical Research Associate II to manage and monitor clinical trials, ensuring regulatory compliance and robust site engagement. The role is based in Sydney with travel to study sites up to 60% of the time.

You will lead monitoring visits, verify source data, manage IP inventory, and maintain essential regulatory documents while collaborating with the study team to meet timelines and quality standards.

Qualifications

• University degree or nursing licensure, or equivalent experience.
• Thorough understanding of ICH GCP guidelines and local regulatory requirements.
• Experience with site monitoring procedures and data quality checks.

Responsibilities

• Manage and monitor clinical trials per SOPs, ICH GCP, and sponsor requirements.
• Perform 100% SDV, query generation, and resolution.
• Maintain site regulatory documents and IP inventory.
• Prepare monitoring plans and site initiation slides; lead CRA activities.
• Assist with training of new staff and travel to study sites as needed.
• Ensure audit readiness and data integrity throughout trials.

Skills

Site management

Clinical monitoring

Regulatory compliance

Data integrity

Travel readiness

Team collaboration

Vendor coordination

Education

University degree in life sciences

Tools

eClinical systems

eTMF

Job description

We’re excited to announce a new opportunity to join our growing team in Australia! We are currently seeking a Clinical Research Associate II (CRA2) who is passionate about advancing clinical research and making a meaningful impact in healthcare. As a CRA2, you will play a key role in managing and monitoring clinical trials, ensuring compliance with regulatory requirements, and fostering strong relationships with investigative sites. This is a fantastic opportunity for professionals looking to grow their career in a dynamic and collaborative environment.

Summary of Responsibilities

Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records. Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits. Prepares and implements project plans related to Clinical Monitoring responsibilities. Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements. Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems. Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial. Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements. Ensures adherence to global quality control and CRA performance metrics. Ensures audit readiness at site level. Acts in the project role of a Lead CRA as assigned.

General On-Site Monitoring Responsibilities

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter subjects/patients into the study. Ensure the protection of study subjects or patients by performing eligibility review, verifying that screening, informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. Ensure the integrity of the source data reported by careful source document review. Monitor data for missing or implausible data. Ensure study data completeness, accuracy, consistency, and compliance; identify deficiencies, deviations and discrepancies, and initiate corrective action as required. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy. Travel, including air travel, may be required and is an essential function of the job. Prepare and submit accurate and timely trip reports. Independently perform eCRF review, 100% source data verification, query generation and resolution against established data review guideline with or without direct supervision, on Fortrea or client data management systems, as assigned by management. Assist with the administration of clinical research projects, recruiting investigators (if applicable), collecting investigator documentation and site management. Update, navigate, and maintain Fortrea or study/Sponsor-specific trial management tools/eClinical systems. Track IP shipments and supplies, as needed. Track and follow-up on serious adverse events as assigned. Work closely with the study team, align monitoring to critical study timelines ensuring study deliverables are met. Prepare and implement study-specific monitoring plans and site Initiation slides, as assigned. Attend investigators’ meetings (if applicable), project team meetings and teleconferences, and others as needed. Present training content for site initiation. Assist with training of new employees (e.g., co-monitoring). All other duties as needed or assigned.

Qualifications (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements. Thorough knowledge of monitoring procedures. Basic understanding of the clinical trial process. Fluent in local office language and in English, both written and verbal. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND Typically 2 years of onsite clinical site monitoring experience (SIV - Close out). Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines. Ability to work with minimal supervision. Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs. Good planning, organization, and problem-solving abilities. Works efficiently and effectively in a matrix environment.

Physical Demands/Work Environment

Location: Incumbent of the role needs to be based in Sydney hand happy to work 3 days from the office if not travelling Will involve outside of normal office hours as required by the role. Travel Requirement is 60% of the time (traveling to study sites). Learn more about our EEO & Accommodations request here.

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At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.