CTA II

Full time, permanent, office-based position at our Melbourne CDB based location. Who are we? We’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’s. If you already work in this industry you’ll know that we are experts in our field. Why should you join Avance Clinical? At Avance we know our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success. The role The Clinical Trial Associate II (CTA II) is responsible for supporting the Clinical Operations Team in an administrative capacity ensuring the trial is conducted in accordance with the protocol, company Standard Operating Procedures (SOPs), ICH GCP guidelines and other applicable regulatory requirements. Please note: this role is office based 5 days per week. Core Responsibilities Support all aspects of clinical operations from study inception to completion, including: Organise, facilitate and take minutes for project/study team and functional group meetings. Establish, maintain and track completeness of Trial Master Files. Prepare Investigator Site Files and establish study documentation for assigned studies as required. Liaise with study team members to ensure good communication across each study. Prepare and collect site documentation in conjunction with Project Manager and Clinical Research Associate, from study start up through to end of study. Manage receipt and shipping of study documentation to Investigator sites, maintain internal trackers. Maintain internal databases and assist the Clinical Operations team in ad hoc duties. 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. Qualifications, Skills and Experience Bachelor’s level degree in life sciences, pharmacy, nursing or equivalent field (highly regarded), or appropriate industry experience. Previous experience as a CTA in a CRO or Pharma company for at least 1 year, or 2-3 years' experience in an equivalent role in a Clinical Trials-related field. Working knowledge of ICH GCP and applicable regulatory requirements. Clear understanding of the requirement to adhere strictly to client confidentiality. Effective written and oral communications skills, including the ability to keep clients, senior management and other stakeholders informed of project updates and other pertinent information. Demonstrated ability to take initiative in problem solving and in exercising good judgment. An understanding of Privacy Legislation as it applies to the Clinical Trial Environment. What next? To join our team please submit your CV & cover letter as one Microsoft Word document. You must have full Australian working rights to be considered. At Avance, difference is encouraged, celebrated and something we strive for. We empower cultural, disability, LGBTI+, and gender equality. ICH GCP / Clinical Trials / CTA / CRC / CRO / Melbourne #J-18808-Ljbffr