Clinical Research Associate I

About the role

AbbVie is looking for a Clinical Research Associate I (CRA I) to join its expanding clinical operations team in Australia. The role supports clinical studies across a diverse portfolio of programs in multiple therapeutic areas, helping to advance studies that can improve patient outcomes.

Key responsibilities

• Monitor activities at clinical investigative sites to ensure successful execution of the protocol and adherence to GCPs, ICH Guidelines, AbbVie SOPs, monitoring plans and quality standards.
• Carry out site qualification, initiation, interim monitoring and closeout visits for Phase 1-4 studies.
• Manage sites without direct authority, motivate site personnel, manage regulatory inspection readiness and ensure timely data submission and reporting of safety events.
• Protect study subjects and train site personnel on the protocol and regulatory requirements.
• Manage investigator payments, maintain expense reports, identify and recommend potential investigators and sites, and report adverse events within 24 hours.
• Participate in WHS programs, follow codes of conduct and perform ad hoc administrative duties.

Required profile

• Minimum of 1 year of clinically related experience, preferably 6 months in clinical research monitoring; on-site monitoring of investigational drug or device trials is required.
• Health-related tertiary qualification (e.g. medical, scientific, nursing) preferred.
• In-depth knowledge of therapeutic indications and of clinical research regulations, ICH/GCP guidelines and applicable laws.
• Strong planning, organisational, analytical and interpersonal skills, with clear communication and good judgment.
• Flexibility to occasionally attend business meetings outside standard hours.