Inhouse Clinical Research Associate

vor 1 Woche


City of Brisbane, Österreich Novotech Vollzeit

Inhouse Clinical Research Associate - Australia Join to apply for the Inhouse Clinical Research Associate - Australia role at Novotech . The Inhouse Clinical Research Associate (IHCRA) provides in‑house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs. This role will be based in Australia and is hybrid, with a minimum required 2 days in the office. Responsibilities Support the clinical team's in‑house activities on assigned projects. Co‑ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs. Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs. Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data. Create the Investigator Site Files, co‑ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA. May assist the CRAs with the preparation of onsite or remote monitoring visits and follow‑up action items from previous monitoring visits. May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close‑out phase. Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous. Minimum 1 year experience as an in‑house CRA or similar role. Benefits & Culture Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, and we support them with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. Seniority level Entry level Employment type Full‑time Job function Research and Science Location: Brisbane, Queensland, Australia #J-18808-Ljbffr



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