Clinical Research Associate I

Job Description

The Clinical Research Associate I (CRA I) supports the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory guidelines, protocols, and quality standards. Responsibilities include site selection, initiation, monitoring visits, reviewing study documentation and data, liaising with site staff, ensuring participant safety, maintaining study files, and assisting with document preparation and submission.

The role requires strong organizational skills, attention to detail, effective communication, and a foundational understanding of Good Clinical Practice (GCP) and relevant regulations. It involves up to 80% travel, inter-state or overseas as needed.

This is an entry-level opportunity to work with AbbVie, recognized on the Fortune 100 Best Companies to Work For list for 8 consecutive years as of 2025

KEY DUTIES AND RESPONSIBILITIES

• Act as the primary contact for investigative sites, providing information on clinical trials and strengthening AbbVie's relationships.
• Train and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles, fostering trusted partnerships.
• Conduct site evaluations, training, routine, and closure monitoring activities in compliance with protocols, GCP, ICH guidelines, SOPs, and quality standards, ensuring participant safety.
• Develop site engagement strategies, gather insights, and utilize engagement tools such as CRM to report progress and impact.
• Connect study protocols, scientific principles, and clinical trial requirements to daily activities.
• Evaluate and support effective patient recruitment and retention strategies based on disease journey insights.
• Build knowledge of therapeutic areas and clinical landscapes to facilitate protocol compliance and patient recruitment.
• Proactively monitor risks, collaborating with the Central Monitoring team to detect performance or safety issues early.
• Resolve site risk signals with critical thinking and understanding of site processes.
• Implement corrective actions to mitigate risks and ensure compliance, adopting a customer-centric approach.
• Support the identification and evaluation of new investigators or sites under supervision.
• Ensure data quality and timely submission, including safety reporting.
• Maintain audit and inspection readiness at assigned sites and manage investigator payments as per contracts.
• Report adverse events within 24 hours according to policies.
• Participate in WHS programs, adhere to policies, and promote safety.
• Follow AbbVie's codes of conduct and compliance policies.
• Perform ad hoc administrative duties as required.

Qualifications

• Tertiary qualification in a health-related discipline (Medical, Scientific, Nursing).
• Knowledge of therapeutic areas and ability to apply scientific concepts in clinical trials.
• Understanding of local regulatory and legal requirements, ICH/GCP guidelines, and policies.
• Experience in clinical research coordination or data management preferred.
• Ability to work collaboratively across functions and develop relationships.
• Strong planning, organizational skills, and efficiency in a dynamic environment.
• Proficiency with technology and tools to support site health and engagement.
• Excellent interpersonal, communication, and presentation skills to build site relationships.

Flexibility and availability are essential, with occasional participation outside standard hours in line with Australia's 'Right to Disconnect' legislation. Willingness to accommodate international meetings is appreciated.

Additional Information

WAYS WE WORK

• All For One AbbVie: Prioritize the common good, collaborate, and solve problems collectively.
• Decide Smart & Sure: Make informed decisions quickly, embrace learning and experimentation.
• Agile & Accountable: Streamline processes, adapt, delegate, and focus on results.
• Clear & Courageous: Foster open dialogue, share information, admit mistakes, and grow.
• Make Possibilities Real: Be curious, challenge the status quo, and find innovative solutions.

CODE OF CONDUCT & BUSINESS INTEGRITY

• Operate with integrity, adhere to laws and ethical standards.
• Maintain the company's reputation through high standards of conduct.
• Prohibition on bribery and illegal gratification, with immediate dismissal for violations.
• Commitment to diversity, inclusion, and community service.

AbbVie is an equal opportunity employer committed to diversity and inclusion. For more details, visit the provided links.