" \u003cdiv class=\"ja-job-details\"\u003e \u003ch2 class=\"title\"\u003eSenior/Clinical Research Associate\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 Taiwan \u003c/li\u003e \u003cli data-id=\"23522\"\u003e Permanent / Full Time \u003c/li\u003e \u003c/ul\u003e \u003cp class=\"date-posted\"\u003e 15/10/2026 \u003c/p\u003e \u003c/div\u003e \u003cdiv class=\"description\"\u003e We\u0026rsquo;re looking for experienced Senior Clinical Research Associates (SCRA\u0026rsquo;s) to join our amazing Clinical Operations team.\u003cbr\u003e\u0026nbsp;\u0026nbsp;\u003cbr\u003eWe\u0026rsquo;re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980\u0026rsquo;s. If you already work in this industry, you\u0026rsquo;ll know that we are experts in our field and you\u0026rsquo;ll recognise that we\u0026rsquo;re a growing organisation.\u003cbr\u003e\u003cbr\u003eWe have a great, employee centric culture and offer excellent long term career prospects. We believe in work / life balance and offer flexible working options for our SCRA\u0026rsquo;s. We\u0026rsquo;ve doubled in size this past two years and have promoted 25% of our people in the last 12 months.\u003cbr\u003e\u0026nbsp;\u0026nbsp;\u003cbr\u003e\u003cstrong\u003e\u003cstrong\u003e\u003cstrong\u003eThe SCRA performs 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\u003eResponsibilities\u003cbr\u003e\u003c/strong\u003e\u003c/strong\u003e\u003c/strong\u003e \u003cul\u003e \u003cli\u003eConduct site and investigator feasibility activities.\u003c/li\u003e \u003cli\u003eDevelop study-related documents or plans under the supervision of the study Project Manager.\u003c/li\u003e \u003cli\u003eFor a multi-site study, oversee and lead the operations of the clinical team as the Lead CRA including development of Clinical Monitoring Plan, study-specific annotated report, reviewing Visit Reports.\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\u003ePerform protocol review as requested.\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.\u003c/li\u003e \u003cli\u003eCollect 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.\u003c/li\u003e \u003cli\u003eParticipate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and respond to audit observations, as required.\u003c/li\u003e \u003cli\u003eEnsure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.\u003c/li\u003e \u003cli\u003eProvide guidance and mentoring to less experienced staff during co-monitoring visits and facilitating accompanied site visits.\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003e\u003cstrong\u003e\u003cstrong\u003e\u0026nbsp;\u0026nbsp;\u003cbr\u003eRequirements\u003cbr\u003e\u003c/strong\u003e\u003c/strong\u003e\u003c/strong\u003e \u003cul\u003e \u003cli\u003eBachelor\u0026rsquo;s level degree in life sciences, pharmacy, nursing or equivalent field.\u003c/li\u003e \u003cli\u003eCurrent or previous experience working as a CRA within a CRO \u0026ndash; 4 plus years preferred\u003c/li\u003e \u003cli\u003eFormal ICH GCP training and a working 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.\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\u003cstrong\u003e\u003cbr\u003eWhat we offer\u003cbr\u003e\u003c/strong\u003e\u003c/strong\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\u003cstrong\u003eWhat next?\u003cbr\u003eAs a growing business we\u0026rsquo;re looking for likeminded people to join us \u0026ndash; we hope that\u0026rsquo;s you.\u003cbr\u003e\u003c/strong\u003e\u003c/strong\u003e \u003cul\u003e \u003cli\u003eTo join our team please submit your\u0026nbsp;CV \u0026amp; cover letter as one Microsoft Word document\u003c/li\u003e \u003cli\u003eYou must have full Australian working rights to be considered as we\u0027re unable to offer sponsorship for this role.\u0026nbsp;\u003c/li\u003e \u003c/ul\u003e \u003cstrong\u003e\u0026nbsp;\u0026nbsp;\u003cbr\u003e\u003cem\u003eAt Avance difference is encouraged, its celebrated and it\u0027s something we strive for. We empower\u0026nbsp;cultural, disability, LGBTI+, and gender equality.\u003cbr\u003e\u003c/em\u003e\u003cbr\u003e\u003c/strong\u003e\u003cstrong\u003ewww.avancecro.com\u003cbr\u003e\u003cbr\u003eCRA / SCRA / Clinical Trials / Taiwan\u0026nbsp;\u003c/strong\u003e \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=\"916109\" value=\"Apply Now\" title=\"Apply Now\" /\u003e \u003c/div\u003e \u003c/div\u003e "