Clinical Research Associate II

🔥 5 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟡 Mid-level

🧪 Clinical Research

👻 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 study teams, AbbVie internal R&D stakeholders, investigators, and site staff • Serve as the primary sponsor point of contact for investigative sites • Align, train, and motivate site staff and principal investigators on clinical trial goals, protocols, and patient treatment principles • Support, guide, and mentor junior personnel on site management activities • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards • Customize site engagement strategies and track their progress and impact • Apply protocol, scientific, and clinical-trial knowledge to daily trial execution • Develop recruitment and retention techniques based on the patient disease journey • Mentor and train less experienced CRAs and support onboarding of junior CRAs • Participate in or lead global and local task forces and initiatives • Conduct continuous risk assessments with the Central Monitoring team • Identify, evaluate, and recommend investigators and clinical trial sites • Ensure data quality, timely data submission, and appropriate safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contract obligations, where applicable

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum of 3 years of clinically related experience • Preferably 2 years of independent clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring approach, onsite and offsite monitoring • Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Advanced communication and superior cross-functional collaboration skills • Superior planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Superior interpersonal, written, verbal, active listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Ability to independently address clinical site issues using functional expertise, critical thinking, and good judgment • Integrity consistent with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment

🏖️ Benefits

• Equal opportunity employer • Commitment to operating with integrity, driving innovation, transforming lives, and serving the community • Remote work availability

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