Clinical Research Associate Ii
vor 4 Wochen
Job Overview Clinical Research Associate II – Sydney Fortrea is a leading global contract research organization (CRO) with decades of clinical development experience, serving pharmaceutical, biotechnology, and medical device customers across more than 20 therapeutic areas. Operating in ~100 countries, Fortrea transforms drug and device development for partners and patients worldwide. CRA Benefits Monitoring cutting‑edge global clinical trials Experienced and supportive managers to grow CRA knowledge and skills Career development pathways Opportunities to work for dedicated sponsors (FSP) and full‑service operators (FSO) Access to AI‑assisted technology to ease workload Responsibilities Responsible for all aspects of study site monitoring including routine monitoring and closeout, maintenance of study files, and conduct of pre‑study and initiation visits; Liaise with vendors and perform other duties as assigned; Manage site activities as prescribed in project plans; Ensure study staff have received proper materials and instructions to safely enrol patients into the study; Protect study patients by verifying informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements; Ensure scientific integrity of data submitted on Case Report Forms (CRFs) or other data collection tools through careful source document review; Use Sponsor and Fortrea resources efficiently by performing required monitoring tasks in accordance with SOPs and established guidelines, including managing travel expenses in an economical fashion; compliance with Fortrea travel policy; Maintain audit readiness at the site level; Prepare accurate and timely trip reports; Participate in and follow up on Quality Control (QC) visits when requested; Track and follow up on Serious Adverse Event (SAE) reporting, prepare SAEs reports and narratives, and ensure follow‑up of SAEs. Qualifications 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 may be substituted as appropriate; Demonstrated experience of at least 18 months in onsite monitoring of global clinical trials from Site Initiation Visit (SIV) to Close‑out; Understanding of local regulatory guidelines; Willingness to travel interstate to attend site monitoring visits; Comfortable with a hybrid schedule, split time between office and home. Employment Details Seniority level: Entry level Employment type: Full‑time Job function: Research, Analyst, and Information Technology Salary: A$110,****** – A$125,****** (Australia) Location: Sydney, New South Wales, Australia Note: This role is for upcoming future opportunities that may arise at Fortrea and requires being based in Sydney, NSW. We are an equal‑opportunity employer and encourage individuals from all backgrounds to apply. For accommodations during the hiring process, please contact our EEO & Accommodations team. #J-18808-Ljbffr
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vor 3 Wochen
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