Job Description

At AbbVie, we don't just run clinical trials. We help bring life-changing medicines to patients who need them most.

We're seeking an experienced Clinical Research Associate II to join our Clinical Operations team and play a critical role in delivering innovative clinical studies across a diverse and exciting portfolio. This is an prospect to partner with leading investigators, influence study success, and contribute to therapies that have the potential to transform patient outcomes. You'll join a high-performing team that values curiosity, accountability, collaboration and continuous learning and be the trusted AbbVie representative for your assigned clinical sites, helping ensure the successful delivery of clinical research while maintaining the highest standards of quality, compliance and patient safety.

If you're an experienced CRA looking for greater ownership, meaningful scientific engagement, and the chance to work with one of the world's leading biopharmaceutical companies, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILTIES

- Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie’s positioning.
- Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
- Conduct site evaluation, site training, routine on-site and off-site monitoring,



and site closure monitoring activities with compliance, protocol and monitoring plans, in accordance with applicable regulations, Valuable Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
- Advanced understanding of site engagement and ability to customise site engagement strategy for assigned studies.
- Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy.
- Connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
- Evaluate and ensure effective recruitment and retention techniques/plans based on the patient’s disease journey.
- Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
- Mentor and train less experienced CRAs on various aspects of work and provides input into their development.
- Responsible for activities assigned by manager and participate in global/local task forces and initiatives.




- Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
- Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
- Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Audit and regulatory inspection readiness at always assigned clinical site.
- Manages investigator payments as per executed contract obligations, as applicable.
- Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
- Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.

📌 Clinical Research Associate II (Sydney)
🏢 Abbvie
📍 Sydney