Clinical Trials Coordinator

Merck; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working arrangements

Job summary

Merck in Sydney seeks a Clinical Trials Coordinator to support trial and site administration across the clinical lifecycle. You will manage documents, CTMS, and budgeting while collaborating with COM/CRM/CRA to hit site-ready dates.

The role requires a degree and strong English, with flexible working arrangements and a team-focused, compliant approach to trials.

Qualifications

• Bachelor's degree or relevant training in office/healthcare.
• Fluent in local language and business English.
• Strong communication with sites and investigators.
• Good understanding of ICH-GCP and Good Documentation Practices.
• Proficient IT skills with MS Office/existing clinical tools.

Responsibilities

• Track essential documents and report safety reports.
• Update CTMS and tracking tools.
• Support trial and site administration across lifecycle.
• Coordinate budgeting, agreements and payments.
• Assist with site start-up and regulatory submissions.
• Organize meetings and training coordination.

Skills

Strong communication

MS Office

Excel

Time management

Independent working

Customer focus

Education

Bachelor's degree or equivalent in office/healthcare

Tools

MS Office

Clinical applications

Job description

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
• 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.

Additional location(s) Compensation Information:

Required Skills:

• Accountability, Analytical Problem