" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eLead Clinical Research Associate\u003c/h2\u003e \u003cdiv class=\"meta\"\u003e \u003cul class=\"classifications\"\u003e \u003cli data-id=\"17130\"\u003e Clinical Trials \u003c/li\u003e \u003cli data-id=\"17132\"\u003e Australia \u003c/li\u003e \u003cli data-id=\"17133\"\u003e Full Time or part-time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 2/10/2026 \u003c/p\u003e \u003c/div\u003e \u003cul class=\"bullet-points\"\u003e \u003cli\u003eAny State\u003c/li\u003e \u003cli\u003eFlexible Working\u003c/li\u003e \u003cli\u003eClinical Trials\u003c/li\u003e \u003c/ul\u003e \u003cdiv class=\"description\"\u003e \u003cstrong\u003eThe Company\u003cbr\u003e \u003c/strong\u003e\u003cbr\u003e Our client is an Australian-owned boutique CRO providing full-service support to pharmaceutical, biotechnology, device companies and institutional research groups across Australia and beyond. With 25+ years of operational and industry experience, they work across therapeutic areas including first-in-human studies, devices, endocrinology, oncology, neurology, gastroenterology, rare and paediatric diseases, and vaccines. Their expertise spans academic, commercial and biotechnology settings, supporting projects from Phase I to Phase III.\u003cbr\u003e\u003cbr\u003e \u003cstrong\u003eThe Opportunity\u003cbr\u003e\u003c/strong\u003e\u003cbr\u003e Due to continued growth, our client is seeking an experienced CRA within Australia. You may currently be a Senior or Principal/Lead CRA looking for a change of scene, new challenges, or an improved work-life balance as a CRA.\u003cbr\u003e \u003cul\u003e \u003cli\u003eLead the identification, qualification, and selection of investigators and trial sites, including conducting feasibility assessments.\u003c/li\u003e \u003cli\u003eOversee full site lifecycle management (pre-study, initiation, monitoring, and close-out) to ensure optimal site performance.\u003c/li\u003e \u003cli\u003eEnsure 100% compliance with ICH-GCP, local regulations (e.g., TGA, NHMRC, Medicines Australia), and internal QMS requirements.\u003c/li\u003e \u003cli\u003eConduct monitoring visits and perform source data verification (SDV) in line with the study monitoring plan to ensure data integrity and patient safety.\u003c/li\u003e \u003cli\u003ePrepare monitoring reports, maintain Trial Master File (TMF), and ensure accurate, complete, and timely documentation.\u003c/li\u003e \u003cli\u003eTrain investigators and site staff on protocol, GCP, and regulatory requirements, and ensure ongoing compliance and competency.\u003c/li\u003e \u003cli\u003eSupport ethics and regulatory submissions, site start-up activities, and ensure all essential materials and approvals are in place.\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eThe Requirements\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003e7-10+ years\u0027 experience as a CRA or in a closely related clinical trial monitoring role.\u003c/li\u003e \u003cli\u003eStrong expertise in clinical monitoring and site management.\u003c/li\u003e \u003cli\u003eExcellent attention to detail, a strong focus on data integrity, and the ability to manage competing priorities.\u003c/li\u003e \u003cli\u003eTertiary qualifications in science, health, nursing, or a related field, along with a current GCP certificate.\u003c/li\u003e \u003cli\u003eStrong knowledge of ICH-GCP, TGA, NHMRC, and Medicines Australia guidelines.\u003c/li\u003e \u003cli\u003eHighly developed communication, planning, organisational, and time management skills.\u003c/li\u003e \u003cli\u003eExcellent written, verbal, and presentation skills.\u003c/li\u003e \u003cli\u003eAble to work independently, identify issues, and escalate them with a proposed resolution plan.\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003eThe Opportunity\u003c/strong\u003e\u003cbr\u003e You will be given direct responsibility to contribute to the success of innovative, life changing products, where the outcomes will be recognised globally. Position title and remuneration will reflect experience level and appointment of a Senior or Principal/Lead CRA will be considered. For more information, please email careers@mexec.com or call 1300 063 932 to speak with our team. Applications should include a cover letter addressed to Marilyn Jones or Mark Thomas and can be submitted online via our website at www.mexec.com \u003c/div\u003e \u003cdiv class=\"apply\"\u003e \u003ca class=\"back-link\" href=\"#\" title=\"Back to search results\"\u003eBack to search results\u003c/a\u003e \u003cinput type=\"button\" class=\"ja-button\" data-job-id=\"4475545\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "