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AbbVie
AbbVie
H1B Visa SponsorConsultingHealthcareManufacturing
AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.
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Clinical Research Associate II - Australia Remote

AbbVie is seeking a Clinical Research Associate II to support clinical trial delivery across Australia through site monitoring, stakeholder collaboration and compliance oversight. The role focuses on patient safety, data quality, recruitment and adherence to applicable clinical research standards.

AUAustraliaRemoteFull-timeJuniorMiddleEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Serve as the primary AbbVie sponsor contact for investigative sites
  • Provide clinical trial context and connect relevant stakeholders with investigative sites
  • Train, align and motivate site teams and principal investigators on trial objectives, protocols and patient treatment principles
  • Conduct site feasibility and evaluation, training, routine on-site and remote monitoring, and close-out monitoring
  • Maintain compliance with regulations, GCP, ICH guidelines, AbbVie procedures and quality standards
  • Create and tailor site engagement plans, gather local insights and measure their impact
  • Translate study protocols and scientific concepts into effective daily trial execution
  • Assess recruitment and retention methods in relation to the patient disease journey
  • Build therapeutic-area, asset, clinical-landscape and patient-journey expertise to support recruitment and protocol compliance
  • Mentor and develop less experienced clinical research associates
  • Contribute to global and local task forces and other initiatives
  • Complete ongoing risk assessments and work with Central Monitoring to identify study performance or patient safety concerns
  • Address site risk signals and implement preventive and corrective action plans
  • Identify, assess and recommend investigators and sites for clinical studies
  • Ensure site data, safety-event reports and follow-up information are submitted accurately and on time
  • Keep assigned sites prepared for audits and regulatory inspections
  • Administer investigator payments in accordance with executed contracts
  • Report adverse events within 24 hours under AbbVie policies
  • Take part in workplace health and safety programs and support a safe work environment
  • Follow AbbVie conduct standards, compliance procedures and required training
  • Complete other administrative and ad hoc responsibilities as needed

Requirements

  • Bachelor’s degree or equivalent, preferably in a health-related discipline such as medicine, science, nursing or pharmacy
  • At least one year of clinically related experience
  • At least six months of clinical research monitoring experience in investigational drug or device trials
  • Experience with healthy-volunteer and first-in-patient trials is highly desirable
  • Familiarity with risk-based monitoring, including on-site and remote monitoring
  • Strong cross-functional collaboration capabilities
  • Strong planning and organisational skills, with the ability to manage competing projects and deadlines
  • Advanced ability to use technology, tools and available resources effectively
  • Strong interpersonal, written, verbal, active-listening and presentation skills
  • Ability to build and use site relationships and trusted partnerships
  • Ability to apply critical thinking and sound judgement to clinical site issues
  • Knowledge of relevant therapeutic-area indications and clinical-trial scientific concepts
  • Advanced knowledge of local regulatory and legal requirements, ICH/GCP guidelines and applicable policies
  • Ability to occasionally attend meetings outside standard business hours when reasonably required for global collaboration
  • Integrity and conduct consistent with AbbVie’s code of business conduct and leadership values

Benefits

  • Flexible and supportive workplace
  • Flexible and accessible hiring process
  • Reasonable accessibility adjustments and accommodations available
  • Right-to-disconnect protections under Australian legislation
  • Support for occasional working-hour flexibility to enable global collaboration

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