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 in immunology by supporting excellence in clinical research • Partner with study teams, 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 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, regulations, GCP, ICH Guidelines, SOPs, and quality standards • Develop and customize site engagement strategies; gather site insights and track strategy impact • Generate and implement patient recruitment and retention techniques based on the disease journey • Mentor and train less experienced CRAs and support local onboarding • Participate in or lead global/local task forces and initiatives • Conduct continuous risk assessments with the Central Monitoring team • Identify, evaluate, and recommend investigators and sites • Ensure data quality, timely data submission, safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to executed contract obligations, as applicable • Implement preventative and corrective action plans to mitigate risk and promote compliance

🎯 Requirements

• Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum of 3 years of clinically related experience • Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials • Familiarity with risk-based monitoring and on-site/off-site monitoring • Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Advanced communication and cross-functional collaboration skills • Strong planning and organizational skills; ability to work effectively with competing projects and deadlines • Ability to leverage technology, tools, and resources for site support • Excellent written, verbal, active listening, presentation, interpersonal, and relationship-building skills • Ability to independently address clinical site issues using functional expertise, critical thinking, and judgment • Integrity in accordance with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Ability to work remotely

🏖️ Benefits

• Remote work option • Equal opportunity employment • Support for reasonable accommodations for US & Puerto Rico applicants • Referral opportunity/program

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