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Clinical Research Associate 2
Emerald ClinicalClinical Research Associate monitoring and managing clinical trial sites in New Zealand for Emerald Clinical Trials, a global clinical research company. Supporting regulatory submissions, site start-up, compliance, documentation, and recruitment across renal, cardiometabolic, and oncology studies.
Core Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates expertise in site management and monitoring within clinical trials, with a strong focus on regulatory compliance, ethical considerations, and effective communication. Proficient in managing trial documentation and fostering collaboration among multidisciplinary teams.
ATS Keywords
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Coordinate investigator and site identification, feasibility assessment, and selection
- Complete monitoring activities according to the Monitoring Plan and prepare monitoring visit reports
- Plan, organize, conduct, and report site evaluation visits
- Prepare and submit regulatory packages and Ethics Committee packages, including importation/exportation requirements
- Negotiate site budgets and coordinate site contract execution
- Track invoicing and ensure timely site payments
- Plan, organize, and conduct site initiation visits
- Develop and maintain monitoring tools and project-specific documents
- Motivate and train investigators and trial site personnel on protocols, investigational products, and trial requirements
- Collect, review, approve, and code essential trial-site documents for Trial Master File filing
- Reconcile in-house Trial Master File and Investigator Site File contents
- Coordinate distribution, tracking, handling, and destruction of investigational products and trial supplies
- Maintain trial information in the clinical trial management system and tracking/reporting tools
- Support strategies to boost recruitment efforts
- Work within the Clinical Operations group to support site management, monitoring, trial implementation, regulatory compliance, and SOP adherence
Requirements
What you’ll need- Tertiary qualifications in a related science or health care discipline
- More than 2 years’ experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical environment
- Experience in renal and/or oncology clinical trials is a plus
- Practical knowledge of ICH-GCP guidelines
- Knowledge of global and local ethical and regulatory research requirements
- Competence in ethical and participant safety considerations
- Competence in site start-up management
- Competence in site conduct management
- Competence in risk management
- Competence in quality management
- Competence in supply management
- Knowledge of scientific concepts and clinical research design
- Competence in issue escalation management
- Competence in negotiation and conflict resolution
- Critical thinking, problem-solving, decision-making, and strategic thinking skills
- Solid interpersonal communication and presentation skills
- Flexibility to work within a multidisciplinary team autonomously and with varied stakeholders
- Ability to adapt to changing organizational priorities and ambiguous environments
- Ability and willingness to travel
Benefits
Comp & perks- Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience
- Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role
- Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders
- Employee Wellbeing: Programs and initiatives designed to promote work-life balance, health, and team connection
- Global engagement surveys
- Recognition programs
- Team-building events
- Global Opportunities: Exposure to diverse projects and clients
- Purpose-driven work contributing to clinical trials that improve lives
- Collaboration and innovation in a global network