Clinical Research Associate (CRA)

Job Description Clinical Research Associate (CRA) Permanent, full-time role with competitive remuneration and benefits Location: Macquarie Park, Sydney, Australia - Home or office based depending on location Career growth: Expand your expertise in a growing, successful industry Professional development: Gain valuable experience in a dynamic, evolving role As 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 Do Responsibilities include, however not limited to: Act as the primary site contact and site manager for allocated clinical research sites Develop and maintain strong site relationships throughout all phases of the trial Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents Develop an in-depth understanding of the study protocol and associated procedures Coordinate and manage site readiness activities in collaboration with other sponsor functions Participate in site selection and site validation activities Conduct remote and on-site monitoring and oversight activities to ensure data integrity and subject safety Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits Prepare clear, comprehensive, and timely visit reports and non-visit contact reports Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance Identify, assess, and resolve site performance, quality, and compliance issues and escalate as required Work in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authorities Maintain information and documentation accurately in CTMS, eTMF, and other relevant systems Contribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practices Support and/or lead audit and inspection activities as needed Perform co-monitoring visits where appropriate Identify and develop new potential sites in line with country strategy and support the development of strong clinical research capability What You Must have Associate 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 environment Strong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelines Working knowledge of Global and Country or Regional Clinical Research Guidelines Hands-on knowledge of Good Documentation Practices Proven site management capability, including site performance and patient recruitment Demonstrated monitoring capability and independent professional judgment Strong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devices Ability to interpret data and metrics and act appropriately Ability to manage complex issues in a solution-oriented manner Ability to perform root cause analysis and implement corrective and preventive actions Fluent in local language and English, with strong verbal and written communication skills Effective time management, organisational, interpersonal, problem-solving, and conflict management skills Ability to work highly independently across multiple protocols, sites, and therapy areas Strong accountability, urgency, and ability to manage multiple priorities in a changing environment Ability to work effectively in a matrix, multicultural environment Strong customer focus and professional demeanour Positive, self-driven, and growth-oriented mindset What You Can Expect The opportunity to own and influence assigned sites across a national clinical research portfolio Exposure to site management, monitoring, start-up, and close-out activities in a highly regulated environment The chance to help grow the clinical research territory by identifying and developing new sites A collaborative, matrixed environment where your expertise and judgement are valued Requires domestic and international travel approximately 65%–75% of working time 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: 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 Mindset 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: 25% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: Yes Hazardous Material(s): N/A Job Posting End Date: 10/10/2026 *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: R417178