Clinical Trials Coordinator

MerckAUS - New South Wales - Macquarie ParkonsiteSalary not postedView the original posting at Merck ↗

Job Description Clinical Trials Coordinator (CTC) Permanent full-time role with competitive remuneration and benefits The ideal candidate will be based Macquarie Park, Sydney, Australia Work with a high performing, agile and passionate team We support flexible working arrangements As a Clinical Trials Coordinator (CTC), you will play a key role in supporting trial and site administration across the clinical trial lifecycle. This is a critical role in helping deliver planned site-ready dates, supporting document management, supply coordination, regulatory submissions, budgeting, agreements and payment activities. Working closely with local stakeholders including Clinical Operations Manager (COM), Clinical Research Manager (CRM) and Clinical Research Associate (CRA). What You Will Do Responsibilities include, however not limited to: Trial and Site Administration Track essential documents and report safety reports Ensure collation and distribution of study tools and documents Update Clinical Trial Management Systems and tracking tools Support clinical and non-clinical supply management in collaboration with other country roles Manage labelling requirements and coordinate/sign translation change requests, where applicable Support the CRAs to enter site staff into the training portal to ensure training compliance Document Management Prepare documents and correspondence Collate, distribute/ship and archive clinical documents, including electronic Trial Master File (eTMF) Assist with eTMF reconciliation and quality control activities Update manuals and documents, such as patient diaries and instructions Support proper destruction of clinical supplies Prepare Investigator Trial File binders Obtain translations of documents Regulatory and Site Start-Up Provide to and collect from investigators forms and lists for site evaluation, site start-up and submissions Obtain, track and update study insurance certificates Support preparation of submission packages for Ethics / Research Governance Office and Regulatory Agencies (RA) Support publication of study results for GCTO and RA, where required by local legislation Budgeting, Agreements and Payments Develop, control, update and close out country and site budgets, including split site budgets Develop, negotiate, approve and maintain contracts, including CTRAs Track and report contract negotiations Update and maintain contract templates in cooperation with Legal Calculate and execute payments to investigators, vendors and grants Ensure adherence to financial and compliance procedures Monitor and track adherence and disclosures Maintain tracking tools and process FCPA documentation in a timely manner Meeting Planning and Support Organise meetings, including study memos, letters and protocols Support local investigator meetings, including invitations, materials, venue management and vendor support as required Support project-related activities as required Participate in inclusion initiatives and occupational health and safety activities as required Digital Proficiency Uses approved clinical systems, document-management tools, trackers, metrics dashboards and collaboration platforms accurately; maintains data quality in assigned systems; and applies basic automation, analytics and approved AI-enabled tools with guidance to complete assigned work efficiently, consistently and compliantly. What You Must Have Bachelor’s degree or relevant job training in office management, administration, finance or healthcare Fluent in local language(s) and business proficient in English Strong communication skills, both written and verbal, including with sites and investigators Good understanding of Global and Country/Regional Clinical Research Guidelines, ICH-GCP and Good Documentation Practices Strong IT skills, including MS Office, Excel and clinical applications, with the ability to adapt quickly to new systems Effective time management, organisation, interpersonal, conflict management and negotiation skills

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