Clinical Research Associate I

🔥 8 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Monitor activities at clinical investigative sites for AbbVie clinical studies • Ensure protocol execution and adherence to federal and local regulations, GCP, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies • Oversee site personnel activities and influence them to meet study objectives • Proactively manage sites and implement action plans to ensure compliance • Ensure regulatory inspection readiness at assigned clinical sites • Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up • Ensure study-subject safety and protection through monitoring-plan and regulatory compliance • Train study-site personnel on protocols and regulatory requirements • Manage investigator payments according to executed contract obligations • Complete expense reports according to applicable guidelines • Identify, evaluate, and recommend potential investigators and clinical sites • Report adverse events within 24 hours according to AbbVie policies and procedures • Participate in AbbVie WHS programs and promote a safe work environment • Adhere to AbbVie codes of conduct and compliance processes • Perform other ad hoc administrative duties as requested

🎯 Requirements

• Appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • Preferably 6 months of clinical research monitoring experience • Experience in on-site monitoring of investigational drug or device trials required • Current in-depth knowledge of relevant therapeutic indications • Current in-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations • Strong planning and organizational skills • Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Ability to understand and follow work processes within the assigned function • Strong analytical and conceptual capabilities • Strong interpersonal and clear communication skills • Ability to address clinical site issues with appropriate guidance and initiate and communicate corrective action • Ability to use functional expertise and exercise good judgment • Demonstrated business ethics and integrity • Flexibility to occasionally participate in business meetings outside standard hours • Ability to work in Australia

🏖️ Benefits

• Flexible and supportive workplace • Flexible and accessible hiring process • Reasonable accessibility adjustments/accommodations • Right to refuse contact outside working hours under Australia’s 'Right to Disconnect' legislation, unless refusal is unreasonable • Equal opportunity and inclusive workplace

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