Clinical Research Associate 2

This is a fully remote position, open to applicants in New Zealand.

📋 Description

• Facilitate the identification of investigators and sites, perform feasibility assessments, and make selections.

• Execute monitoring activities in accordance with the Monitoring Plan and compile monitoring visit reports.

• Organize, conduct, and document site evaluation visits.

• Prepare and submit regulatory and Ethics Committee documentation, including import and export requirements.

• Negotiate site budgets and oversee the execution of site contracts.

• Monitor invoicing and guarantee timely payments to sites.

• Plan, organize, and carry out site initiation visits.

• Create and maintain monitoring tools and project-specific documentation.

• Inspire and educate investigators and trial site personnel on protocols, investigational products, and trial requirements.

• Collect, review, approve, and code essential trial-site documents for inclusion in the Trial Master File.

• Reconcile the contents of the in-house Trial Master File and Investigator Site File.

• Coordinate the distribution, tracking, handling, and disposal of investigational products and trial supplies.

• Maintain trial information within the clinical trial management system and tracking/reporting tools.

• Support initiatives aimed at enhancing recruitment efforts.

• Collaborate with the Clinical Operations team to assist in site management, monitoring, trial implementation, regulatory compliance, and adherence to SOPs.

⛳️ Requirements

• Relevant tertiary qualifications in a science or healthcare discipline.

• Over 2 years of experience in on-site monitoring and site management in academic, CRO, or pharmaceutical settings.

• Experience in renal and/or oncology clinical trials is advantageous.

• Practical understanding of ICH-GCP guidelines.

• Familiarity with global and local ethical and regulatory research requirements.

• Proficiency in ethical considerations and participant safety.

• Expertise in site start-up management.

• Proficiency in site conduct management.

• Expertise in risk management.

• Expertise in quality management.

• Knowledge of supply management.

• Understanding of scientific concepts and clinical research design.

• Competence in issue escalation management.

• Skills in negotiation and conflict resolution.

• Strong critical thinking, problem-solving, decision-making, and strategic thinking abilities.

• Excellent interpersonal communication and presentation skills.

• Flexibility to work autonomously within a multidisciplinary team and engage with diverse stakeholders.

• Capability to adapt to shifting organizational priorities and navigate ambiguous environments.

• Willingness and ability to travel.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Enjoy hybrid or remote working options based on your location and role.

• Career Growth: Access to extensive learning opportunities and a global network of scientific leaders.

• Employee Wellbeing: Programs and initiatives aimed at promoting work-life balance, health, and team connection.

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Global Opportunities: Exposure to a variety of projects and clients.

• Purpose-driven work contributing to clinical trials that enhance lives.

• Collaboration and innovation within a global network.