" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eCRA I\u003c/h2\u003e \u003cdiv class=\"meta\"\u003e \u003cul class=\"classifications\"\u003e \u003cli data-id=\"23519\"\u003e Clinical Operations \u003c/li\u003e \u003cli data-id=\"23520\"\u003e CRA \u003c/li\u003e \u003cli data-id=\"23521\"\u003e Sydney \u003c/li\u003e \u003cli data-id=\"23522\"\u003e Permanent / Full Time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 30/9/2026 \u003c/p\u003e \u003c/div\u003e \u003cdiv class=\"description\"\u003e At \u003cstrong\u003eAvance Clinical\u003c/strong\u003e, we\u0027re helping innovative biotech and pharmaceutical companies bring life-changing therapies to patients faster. Following significant growth and new global project wins, we\u0027re expanding our team and looking for multiple CRA III\u0026rsquo;s \u0026amp; Senior CRA I\u0026rsquo;s to join our Australian team.\u003cbr\u003e\u003cbr\u003e\u003cbr\u003eWhy Join Avance Clinical? \u003cbr\u003e\u003cstrong\u003eGlobal Recognition:\u003c/strong\u003e Work for the CRO recognised by Frost \u0026amp; Sullivan as the 2026 Global Company of the Year for excellence in biotech CRO leadership.\u003cbr\u003e \u003cstrong\u003eWork Anywhere in Australia:\u003c/strong\u003e Enjoy genuine flexibility and autonomy with a fully remote role supported by industry-leading technology and a highly collaborative culture.\u003cbr\u003e \u003cstrong\u003eAccelerate Your Career:\u003c/strong\u003e Join one of Australia\u0027s fastest-growing CROs, where high performers are recognised and supported to advance their careers.\u003cbr\u003e \u003cstrong\u003eMeaningful, Diverse Projects:\u003c/strong\u003e Work with emerging biotech companies developing the next generation of therapies.\u003cbr\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u003cbr\u003e\u003cstrong\u003eOpportunity\u003c/strong\u003e\u003cbr\u003e We have full-time permanent position for a CRA I to join us.\u003cbr\u003e \u003cbr\u003e The Clinical Research Associate I (CRA I) perform activities associated with the evaluation, initiation, monitoring and close out of clinical trials to ensure the trial is conducted in accordance with the protocol; company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements.\u003cbr\u003e \u003cbr\u003e This role would suit someone early in their clinical trial career with around 12 months experience in a GCP environment. \u003cbr\u003e \u003cbr\u003e \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eResponsibilities\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eConduct site and investigator feasibility activities.\u003c/li\u003e \u003cli\u003ePerform all activities (preparation, execution, and follow-up) associated with onsite or remote Pre-Study Visits (PSV), Study Initiation Visits (SIV), Dose Witness Visits (DWV), Interim Monitoring Visits (IMV) and Close-out Visits (COV).\u003c/li\u003e \u003cli\u003eGenerate and maintain high-quality confirmation letters, site visit reports, follow-up letters and other documentation related site monitoring and management to ensure compliance with ICH GCP, study protocol and regulatory requirements.\u003c/li\u003e \u003cli\u003eMonitor participant source data, review Investigator Site Files (ISF), perform Investigational Product accountability, meet with site personnel, and ensure procedures are conducted in accordance with the protocol and ICH GCP.\u003c/li\u003e \u003cli\u003eRaise data queries in the Case Report Form (CRF) where discrepancies are identified and work with site staff to ensure timely and accurate resolution. Collect TMF documentation from site and ensure accurate and timely filing as per SOP requirements.\u003c/li\u003e \u003cli\u003eMaintain effective site communication to proactively manage on-going study expectations and issues. Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required. Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.\u003c/li\u003e \u003c/ul\u003e \u003cbr\u003e \u0026nbsp;\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eRequirements\u003c/strong\u003e\u0026nbsp;\u0026nbsp;\u003cbr\u003e \u003cul\u003e \u003cli\u003eBachelor\u0026rsquo;s level degree in life sciences, pharmacy, nursing, or equivalent field.\u003c/li\u003e \u003cli\u003ePrevious exposure to a Clinical Trials environment with around 12 months experience as a CTA, CRC, Junior CRA or similar.\u003c/li\u003e \u003cli\u003eFormal ICH GCP training (desirable) and a well-developed knowledge of ICH GCP Guidelines and other applicable regulatory requirements.\u003c/li\u003e \u003cli\u003eClear understanding of the requirement to adhere strictly to client confidentiality.\u003c/li\u003e \u003cli\u003eEffective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information.\u003c/li\u003e \u003cli\u003eDemonstrated ability to take initiative in problem solving and in exercising good judgment.\u003c/li\u003e \u003cli\u003eAwareness of Privacy Legislation as it applies to the Clinical Trial environment (desirable).\u003c/li\u003e \u003cli\u003eAbility to work under pressure in a multi-disciplinary team environment.\u003c/li\u003e \u003cli\u003eWillingness to work in, and be supportive of, a positive and dynamic team culture.\u003c/li\u003e \u003cli\u003eAbility to travel. Moderate level of interstate travel may be required (up to 50%).\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eWhat we offer\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eStimulating work\u003c/li\u003e \u003cli\u003eProject diversity\u003c/li\u003e \u003cli\u003eAn intellectual challenge\u003c/li\u003e \u003cli\u003eAn agile \u0026amp; flexible workplace\u003c/li\u003e \u003cli\u003eOpportunity to progress\u003c/li\u003e \u003cli\u003eStability\u003c/li\u003e \u003cli\u003eSense of community\u003c/li\u003e \u003cli\u003eA leadership team that are working together on a common goal\u003c/li\u003e \u003cli\u003eFlexible work options\u003c/li\u003e \u003cli\u003eGreat tools / tech to do your job\u003c/li\u003e \u003cli\u003eA competitive salary \u0026amp; an extra days holiday for your birthday!\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u0026nbsp;\u003cbr\u003e \u003cstrong\u003eWhat next?\u003c/strong\u003e\u003cbr\u003e \u003cul\u003e \u003cli\u003eApply online\u003c/li\u003e \u003cli\u003eYou must have full Australian working rights to be considered\u003c/li\u003e \u003c/ul\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u003cbr\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e \u0026nbsp;\u0026nbsp;\u003cbr\u003e CRA / CRC / CTA / Clinical Research / CRO / Clinical Trials / Sydney / NSW / Adelaide / South Australia / Melbourne / Victoria / Work from home / Remote \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=\"910156\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "