Clinical Trials Coordinator

Job description

Job Description Clinical Trials Coordinator (CTC) Permanent full-time role with competitive renumeration 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 High accountability and urgency, with the ability to prioritise and manage multiple tasks in a changing environment Ability to work independently and in a matrix, multicultural environment Strong customer focus and a proactive, solution-oriented mindset What You Can Expect The opportunity to contribute to the successful delivery of clinical trials A collaborative team environment working closely with cross-functional stakeholders Ongoing support, development and growth in your role We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace. Required Skills: Analytical Problem Solving, Clinical Data Management, Clinical Documentation, Clinical Reporting, Clinical Research Administration, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Regulations, Clinical Trials Administration, Clinical Trial Support, Data Analysis, Good Clinical Practice (GCP), Medical Documentation, Recordkeeping, Reporting Tools Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 09/22/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.