Clinical Research Associate (CRA)

MerckNZL - Auckland - NewmarketonsiteSalary not postedView the original posting at Merck ↗

Job Description Clinical Research Associate (CRA) Permanent, full-time role with competitive remuneration and benefits Location: Auckland, New Zealand 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-orient

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