Clinical Research Associate

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

📋 Description

• Facilitate the identification, feasibility assessment, and selection of investigators and sites.

• Execute monitoring activities as outlined in the Monitoring Plan and generate monitoring visit reports.

• Organize, conduct, and report on site evaluation visits.

• Prepare and submit regulatory documentation and manage Ethics Committee submissions.

• Oversee site budgets, contracts, invoicing, and payment processing.

• Plan, organize, and conduct site initiation visits.

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

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

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

• Reconcile 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.

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

• Assist in developing strategies to enhance trial recruitment.

⛳️ Requirements

• Tertiary qualifications in a relevant science or healthcare discipline.

• A minimum of 2 years’ experience in on-site monitoring and site management within clinical trials is essential.

• Experience in academic, CRO, or pharmaceutical clinical trial settings.

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

• Practical understanding of ICH-GCP guidelines along with global and local ethical and regulatory research standards.

• Proficient in ethical and participant safety considerations, site start-up and conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.

• Skilled in negotiation, conflict resolution, critical thinking, problem-solving, decision-making, and strategic thinking.

• Strong interpersonal communication and presentation abilities.

• Capable of working independently as well as collaboratively within a multidisciplinary team with diverse stakeholders.

• Adaptable and flexible in response to changing priorities and uncertain environments.

• Willingness and ability to travel.

🏝️ Benefits

• Competitive compensation: customized salary and benefits package.

• Hybrid or remote working options, depending on location and position.

• Opportunities for learning and access to a global network of scientific leaders.

• Employee wellbeing programs and initiatives promoting work-life balance, health, and team connectivity.

• Global engagement surveys.

• Recognition programs.

• Team-building events.

• Exposure to a variety of projects and clients through international outreach.