Job DescriptionClinical Research Associate (CRA)Permanent, full-time role with competitive remuneration and benefitsLocation: Macquarie Park, Sydney, Australia - Home or office based depending on locationCareer growth: Expand your expertise in a growing, successful industryProfessional development: Gain valuable experience in a dynamic, evolving roleAs a Clinical Research Associate, you will be accountable for the performance and compliance of assigned protocols and sites within a country. Reporting to the CRA Manager, you will ensure study conduct aligns with ICH-GCP, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.This role acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. You will also contribute to territory growth by identifying and developing new sites, while sharing best practices and supporting monitoring capability within the wider CRA team.What You Will DoResponsibilities include, however not limited to:Act as the primary site contact and site manager for allocated clinical research sitesDevelop and maintain strong site relationships throughout all phases of the trialPerform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documentsDevelop an in-depth understanding of the study protocol and associated proceduresCoordinate and manage site readiness activities in collaboration with other sponsor functionsParticipate in site selection and site validation activitiesConduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safetyConduct site visits including validation visits, initiation visits, monitoring visits, and close-out visitsPrepare clear, comprehensive, and timely visit reports and non-visit contact reportsCollect, review, and monitor regulatory documentation for study start-up, maintenance, and close-outCommunicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performanceIdentify, assess, and resolve site performance, quality, and compliance issues and escalate as requiredWork in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authoritiesMaintain information and documentation accurately in CTMS, eTMF, and other relevant systemsContribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practicesSupport and/or lead audit and inspection activities as neededPerform co-monitoring visits where appropriateIdentify and develop new potential sites in line with country strategy and support the development of strong clinical research capabilityWhat You Must haveAssociate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, including direct site management experience in a bio, pharma, or CRO environment, or a bachelor’s degree or above with direct site management experience in a bio, pharma, or CRO environmentStrong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelinesWorking knowledge of Global and Country or Regional Clinical Research GuidelinesHands-on knowledge of Good Documentation PracticesProven site management capability, including site performance and patient recruitmentDemonstrated monitoring capability and independent professional judgmentStrong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devicesAbility to interpret data and metrics and act appropriatelyAbility to manage complex issues in a solution-oriented mannerAbility to perform root cause analysis and implement corrective and preventive actionsFluent in local language and English, with strong verbal and written communication skillsEffective time management, organisational, interpersonal, problem-solving, and conflict management skillsAbility to work highly independently across multiple protocols, sites, and therapy areasStrong accountability, urgency, and ability to manage multiple priorities in a changing environmentAbility to work effectively in a matrix, multicultural environmentStrong customer focus and professional demeanourPositive, self-driven, and growth-oriented mindsetWhat You Can ExpectThe opportunity to own and influence assigned sites across a national clinical research portfolioExposure to site management, monitoring, start-up, and close-out activities in a highly regulated environmentThe chance to help grow the clinical research territory by identifying and developing new sitesA collaborative, matrixed environment where your expertise and judgement are valuedRequires domestic and international travel approximately 65%–75% of working timeWe 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: Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Documentation, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth MindsetPreferred Skills:Current Employees applyCurrent Contingent Workers applySearch 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: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: RemoteShift: Not IndicatedValid Driving License: YesHazardous Material(s): N/AJob Posting End Date: 10/10/2026