IQVIA

Clinical Research Associate 2

IQVIA

full-time

Posted on:

Location Type: Hybrid

Location: Auckland • 🇳🇿 New Zealand

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Job Level

JuniorMid-Level

Tech Stack

Google Cloud Platform

About the role

  • 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.

Requirements

  • Bachelor's 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
on-site monitoringclinical research regulatory requirementsGood Clinical Practice (GCP)International Conference on Harmonization (ICH)protocol compliancedata query resolutionquality controlproject timelinessubject recruitment plansfinancial management
Soft skills
written communicationverbal communicationorganizational skillsproblem-solving skillstime managementrelationship buildingteam collaborationexpectation managementfeedback provisioncontingency planning