Hybrid Clinical Research Associate 2 RSU

This role is an unique opportunity which offers a mixture of CRA and Regulatory start up exposure in Auckland New Zealand!

Responsibilities:

• Conduct site visits (selection initiation monitoring and close-out) per GCP/ICH guidelines and contracted scope of work.
• Evaluate site practices for protocol compliance and escalate quality issues as appropriate.
• Administer protocol and study-related training to sites; maintain regular communication to manage expectations and resolve issues.
• Track regulatory submissions recruitment and enrollment CRF completion and data query resolution.
• Ensure TMF and ISF compliance with GCP and local regulations.
• Document monitoring findings visit reports follow-up letters and other required study records.

• Collaborate with sites to develop and track subject recruitment plans to meet project needs.
• If applicable manage site financials per clinical trial agreements and retrieve invoices according to local requirements.

• Liaise with sponsors on specific initiatives as needed.
• Work closely with study team members to support project execution.

• Serve as SPOC for assigned studies liaising with sites SAMs and internal teams.
• Prepare and review site regulatory documents for completeness and accuracy.
• Perform start-up and activation activities per SOPs WIs and regulatory requirements.
• Distribute completed documents to sites and internal stakeholders.
• Track progress of approvals ethics submissions ICFs and Investigator Pack (IP) release in line with project timelines.
• Inform team members upon completion of regulatory and contractual documents.
• Provide local expertise during initial and ongoing project planning.
• Perform quality control of documents provided by sites.

• Review and agree on project timelines; monitor progress and implement contingency plans as needed.
• Review site performance metrics and provide feedback to management.
• Maintain accurate project-specific information in internal systems databases and tracking tools.

Qualifications:

• Bachelors Degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements (i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers managers and clients.

Benefits:

• Well-established onboarding and continuous training and development opportunities
• IQVIA benefits including extra leave and health allowance
• Being part of a company that promotes and supports a healthy work life balance
• Strong stable and experienced team and supportive managers
• Fantastic inclusive IQVIAN work culture

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at