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Clinical Research Associate

2+ years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate (CRA)

Location: Level 6, 2-6 Crowhurst Street, Newmarket, 1023, New Zealand
Job ID: 3385
Schedule: Full-time
Posting Date: 12 September 2025, 07:16 AM


Company Overview

Novotech is a global full-service Clinical Contract Research Organization (CRO):

  • Headquartered in Sydney, Australia, with 34 offices across Asia-Pacific, North America, and Europe.

  • Employs over 3,000 employees and partners with 5,000+ clinical sites.

  • Offers services across all clinical trial phases and therapeutic areas, including:

    • Feasibility assessments

    • Ethics and regulatory submissions

    • Data management & statistical analysis

    • Medical monitoring & safety solutions

    • Central lab services

    • Report writing to ICH requirements

    • Project & vendor management

  • Certified with ISO 27001 (Information Security) and ISO 9001 (Quality Management).


Role Overview

The Clinical Research Associate (CRA II / CRA III) ensures the rights and wellbeing of trial participants and that trial data are accurate, complete, and verifiable. The CRA is the primary contact between Investigational Sites, Novotech, and Sponsors, serving as a site relationship manager to ensure trials comply with ICH GCP guidelines, local and global regulations, and SOPs.

  • Offers hybrid work arrangements and flexible hours for work-life balance.


Minimum Qualifications & Experience

  • Education: Graduate in clinical or life sciences-related field (allied professions considered).

  • Experience:

    • CRA II: Minimum 6 months of independent CRA monitoring experience

    • CRA III: 2+ years of independent CRA monitoring experience

  • Skills:

    • Time management, attention to detail, team collaboration, and computer literacy


Key Responsibilities

Site Relationship & Trial Management

  1. Build relationships with Principal Investigators, study coordinators, pharmacists, and site personnel.

  2. Ensure efficient and timely trial management per study requirements.

  3. Collaborate with In-house CRA (IHCRA) and Regulatory Start-up Associate (RSA) to prepare site essential documents and support ethics/regulatory approvals.

  4. Understand applicable local and international regulatory requirements with the RSU team.

  5. Drive site recruitment and engagement initiatives; prepare and update site-specific recruitment plans.

Monitoring & Compliance

  1. Monitor investigational sites per ICH GCP across all trial phases:

    • Site Selection

    • Site Initiation

    • Site Monitoring

    • Site Close Out

    • Unblinded pharmacy visits and co-monitoring visits

  2. Conduct visits onsite or remotely as per CMP guidelines.


Workplace & Culture

  • Supports flexible working options, parental leave, wellness programs, and ongoing development.

  • Inclusive work environment for all, including LGBTIQ+, people with disabilities, or those with caring responsibilities.

  • Circle Back Initiative Employer: committed to responding to every application.


Team & Career Growth

  • Opportunity to work with empowered teams on cutting-edge clinical research.

  • Culture fostering partnership, collaboration, and strategic decision-making.

  • Ongoing support from senior stakeholders and leadership for professional development.