Clinical Trials Coordinator

Job Description

Clinical Trials Coordinator (CTC)

Permanent full-time role with competitive renumeration and benefitsThe ideal candidate will be based Macquarie Park, Sydney, AustraliaWork with a high performing, agile and passionate teamWe 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 reportsEnsure collation and distribution of study tools and documentsUpdate Clinical Trial Management Systems and tracking toolsSupport clinical and non-clinical supply management in collaboration with other country rolesManage labelling requirements and coordinate/sign translation change requests, where applicableSupport the CRAs to enter site staff into the training portal to ensure training compliance

Document Management

Prepare documents and correspondenceCollate, distribute/ship and archive clinical documents, including electronic Trial Master File (eTMF)Assist with eTMF reconciliation and quality control activitiesUpdate manuals and documents, such as patient diaries and instructionsSupport proper destruction of clinical suppliesPrepare Investigator Trial File bindersObtain translations of documents

Regulatory and Site Start-Up

Provide to and collect from investigators forms and lists for site evaluation, site start-up and submissionsObtain, track and update study insurance certificatesSupport 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 budgetsDevelop, negotiate, approve and maintain contracts, including CTRAsTrack and report contract negotiationsUpdate and maintain contract templates in cooperation with LegalCalculate and execute payments to investigators, vendors and grantsEnsure adherence to financial and compliance proceduresMonitor and track adherence and disclosuresMaintain tracking tools and process FCPA documentation in a timely manner

Meeting Planning and Support

Organise meetings, including study memos, letters and protocolsSupport local investigator meetings, including invitations, materials, venue management and vendor support as requiredSupport project-related activities as requiredParticipate 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 healthcareFluent in local language(s) and business proficient in EnglishStrong communication skills, both written and verbal, including with sites and investigatorsGood understanding of Global and Country/Regional Clinical Research Guidelines, ICH-GCP and Good Documentation PracticesStrong IT skills, including MS Office, Excel and clinical applications, with the ability to adapt quickly to new systemsEffective time management, organisation, interpersonal, conflict management and negotiation skillsHigh accountability and urgency, with the ability to prioritise and manage multiple tasks in a changing environmentAbility to work independently and in a matrix, multicultural environmentStrong customer focus and a proactive, solution-oriented mindset

What You Can Expect

The opportunity to contribute to the successful delivery of clinical trialsA collaborative team environment working closely with cross-functional stakeholdersOngoing 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

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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.

Requisition ID R413402