Clinical Research Associate 2 - Auckland, New Zealand

Company Overview

Emerald Clinical Trials is a prominent global clinical research organization collaborating with over 160 biotech companies and 15 of the leading 20 pharmaceutical firms worldwide. Headquartered in Singapore, the company specializes in comprehensive clinical trial services from Phase I to IV, including real-world studies, with over 25 years of expertise especially in renal research.

With a team of 1000+ employees across Asia-Pacific, Europe, and the Americas, Emerald Clinical combines scientific excellence with operational expertise to accelerate recruitment, enhance patient engagement, and deliver impactful clinical outcomes.

Role Summary

The Clinical Research Associate 2 joins the Clinical Operations team, responsible for managing clinical trial sites, conducting monitoring visits, and supporting operational tasks while ensuring compliance with regulatory standards and SOPs.

Primary Duties

• Manage site identification, feasibility evaluations, and investigator selection for clinical trials.
• Carry out monitoring visits according to the Monitoring Plan and prepare timely, accurate monitoring reports.
• Conduct and report on site evaluation visits to aid in site selection.
• Collaborate with regulatory specialists to prepare regulatory submissions, including Ethics Committee documentation and import/export requirements.
• Negotiate budgets and contracts with trial sites, oversee invoicing, and ensure payments are processed efficiently.
• Plan and execute site initiation visits with appropriate documentation.
• Develop and update monitoring tools and project documentation.
• Train and support trial site staff to ensure understanding of protocols and trial obligations, ensuring compliance and quality through review of essential documents and Trial Master File management.
• Reconcile Investigator Site Files contents with internal Trial Master File documentation.
• Oversee investigational product and trial supply logistics, including distribution, tracking, handling, and disposal.
• Maintain trial data within clinical trial management systems and other tracking tools.
• Assist in enhancing recruitment strategies to support trial enrolment.

Candidate Requirements

• Degree in a relevant science or healthcare field.
• Minimum of two years’ hands-on experience in onsite monitoring and site management in clinical research within academia, a CRO, or pharmaceutical setting.
• Additional experience in renal and/or oncology clinical trials is advantageous.
• Thorough understanding of ICH-GCP guidelines and compliance with global and local ethical and regulatory standards.
• Strong skills in ethical and participant safety considerations, site start-up and management, risk and quality management, supply logistics, clinical research design, and issue escalation.
• Business acumen including negotiation, conflict resolution, critical thinking, problem-solving, and strategic decision making.
• Excellent interpersonal communication and presentation skills with the ability to work autonomously and collaboratively within multidisciplinary teams.
• Adaptability to dynamic and evolving organizational priorities.
• Willingness and ability to travel as required.

Additional Information

This position is currently open for talent pooling; the role is not yet active but applications are accepted for future consideration.

Why Join Emerald Clinical?

• Engage in meaningful work with clinical trials focused on renal, cardiometabolic, and oncology therapies that impact lives globally.
• Benefit from a global company with local expertise and community engagement.
• Work within a culture that fosters collaboration, innovation, and diversity of perspectives.

Benefits

• Competitive and customized salary and benefits package.
• Options for hybrid or fully remote work based on role and location.
• Opportunities for career advancement supported by extensive learning programs and global scientific networks.
• Employee wellbeing initiatives promoting work-life balance, health, and team cohesion.
• Exposure to international projects and clients within a global organization.

Equal Opportunity

Emerald Clinical is committed to equal opportunity employment and encourages applications from all qualified individuals.