# Clinical Research Associate II (CRA2) **Company**: Fortrea **Work arrangement**: hybrid **Experience**: mid **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Melbourne/Clinical-Research-Associate-II---Melbourne--Adelaide--or-Perth_261586?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_49bafee1-ecc ## 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. - 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, 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, project team meetings and teleconferences, and others as needed. - Present training content for site initiation. - Assist with training of new employees. **Qualifications (Minimum Required):** - University or college degree, or certification in a related allied health profession from an appropriately accredited institution. - 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. **Experience (Minimum Required):** - Typically 2 years of onsite clinical monitoring experience. - 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 Melbourne, Adelaide or Perth. - Will involve outside of normal office hours as required by the role. - Travel Requirement is 60% of the time (traveling to study sites). ## Skills ### Required - ICH GCP Guidelines - clinical trial process - monitoring procedures - English --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Melbourne/Clinical-Research-Associate-II---Melbourne--Adelaide--or-Perth_261586?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)