Clinical Research Associate I

Job Description

The Clinical Research Associate I (CRA I) is responsible for supporting the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory guidelines, protocols, and quality standards. The CRA I assists in site selection, initiation, and monitoring visits, reviews study documentation and data for accuracy and completeness, liaises with site staff to address study-related issues, ensures the safety and well-being of study participants, maintains essential study files, and assists in the preparation and submission of study documents.

The role requires strong organisational skills, attention to detail, effective communication, and a foundational understanding of Good Clinical Practice (GCP) and relevant regulations. It is expected for this role to have up to 80% travel inter-state or overseas as required.

This is a unique, entry-level opportunity to work with AbbVie, recognized on the Fortune 100 Best Companies to Work For list for the 8th year in a row in 2025

1. Act as the primary point of contact for investigative sites, providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning.
2. Align, train, and motivate site staff and principal investigators under supervision on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership.
3. Conduct site evaluations, training, routine, and site closure monitoring activities under supervision, in compliance with the protocol, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects.
4. Customize site engagement strategies for assigned studies under supervision, gather local/site insights, and utilize site engagement tools such as CRM to report, track progress, and measure impact.
5. Develop fundamental knowledge connecting the study protocol, scientific principles, and clinical trial requirements to day-to-day trial activities.
6. Evaluate and ensure effective recruitment and retention techniques based on the patient disease journey.
7. Develop knowledge of the therapeutic area, assets, and clinical landscape to enable successful patient recruitment and protocol compliance.
8. Proactively monitor activities conducted by clinical sites to detect early study performance or patient safety issues, in collaboration with the Central Monitoring team.
9. Think critically to resolve site risk signals while understanding site processes to drive study execution.
10. Implement preventative and corrective actions to mitigate risks and promote compliance using a customer-centric approach.
11. Identify, evaluate, and recommend new or potential investigators/sites under supervision, supported by experienced CRAs.
12. Ensure data quality from study sites and timely submission of data, including safety reporting.
13. Maintain audit and inspection readiness at assigned sites and manage investigator payments as per contracts.
14. Report any adverse events within 24 hours as per policies and procedures.
15. Participate in AbbVie's WHS programs, adhere to policies, and promote a safe work environment.
16. Adhere to AbbVie's codes of conduct and compliance processes.
17. Perform other duties as assigned, including administrative tasks.

• Tertiary qualification in a health-related discipline (Medical, Scientific, Nursing).
• Knowledge of therapeutic area indications, with the ability to understand and apply scientific concepts related to clinical trials.
• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Experience in clinical research coordination or data management preferred.
• Ability to work collaboratively across functions to develop and maintain relationships.
• Strong planning and organizational skills to work effectively in a dynamic environment with multiple deadlines.
• Proficiency in leveraging technology and tools to support site health and clinical trial activities.
• Strong interpersonal, communication, and presentation skills to establish trusted site relationships.

Flexibility and availability are essential, with recognition of Australia's 'Right to Disconnect' legislation. Participation in meetings outside standard hours may be required occasionally.

• All For One Abbvie: We prioritize the common good, inspiring teamwork and problem-solving for all.
• Decide Smart & Sure: We make informed decisions quickly, embracing experimentation and learning.
• Agile & Accountable: We streamline processes, adapt as needed, delegate, and focus on results.
• Clear & Courageous: We foster open, honest dialogue, share information, admit mistakes, and grow stronger.
• Make Possibilities Real: We challenge ourselves to find creative solutions and turn possibilities into reality.

• AbbVie commits to high integrity and ethical standards in all dealings.
• We adhere to laws and operate responsibly, maintaining our reputation for conduct and compliance.
• Soliciting or accepting bribes or illegal gratification results in immediate dismissal.
• We are dedicated to innovation, community service, diversity, and inclusion.

AbbVie is an equal opportunity employer, committed to diversity and inclusion. For more information, visit our website links provided.