Clinical Research Associate II

🔥 0 minutes ago

🇨🇳 China – 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

• Advance AbbVie’s clinical development pipeline through excellence in clinical research • Partner with investigators and site staff to support effective clinical trial engagements • Serve as the primary point of contact for the investigative site • Provide contextual clinical trial information and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocol, and patient treatment principles • Conduct site evaluation, site training, routine monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards • Customize site engagement strategies and track their progress and impact using CRM tools • Apply protocol, scientific, and clinical trial knowledge to day-to-day trial execution • Evaluate recruitment and retention techniques based on the patient disease journey • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge • Mentor and train less experienced CRAs and contribute to their development • Participate in global/local task forces and initiatives • Conduct continuous risk assessment in collaboration with the Central Monitoring team • Resolve site risk signals and implement preventative and corrective action plans • Identify and recommend potential investigators and sites • Ensure timely, complete, and high-quality site data and safety-event reporting • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contract obligations, as applicable

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience on investigational drug or device trials • Familiarity with risk-based monitoring, onsite and offsite monitoring • Knowledge of appropriate therapeutic area indications preferred • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills • Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools and resources for customer-centric site support • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships and trusted partnerships • Ability to apply critical thinking and good judgment to clinical site issues • Ability to act with integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes

🏖️ Benefits

• Employees can work remotely • Equal opportunity employer • Reasonable accommodation for US & Puerto Rico applicants

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