Senior Clinical Research Associate

🔥 36 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Serve as the primary sponsor point of contact for investigative sites • Provide contextual information on clinical trials and connect stakeholders with 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, AbbVie SOPs, and quality standards • Develop and customize site engagement strategies and track their progress and impact • Apply scientific principles, clinical trial requirements, and therapeutic-area knowledge to trial execution • Generate recruitment and retention techniques and plans based on the patient disease journey • Mentor and train less experienced CRAs and support local onboarding • Participate in or lead global and local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend potential investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to executed contract obligations, as applicable

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum of 3 years of clinically related experience • 2 years preferable in independent clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring approach, onsite and offsite monitoring • Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials • Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Advanced communication and 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 to provide customer-centric site support • Superior written, verbal, active listening, presentation, and interpersonal skills • Ability to establish and leverage site relationships and trusted partnerships • Ability to independently address clinical site issues using functional expertise, critical thinking, and good judgment • Integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated focus on timely, quality outcomes in a fast-paced environment

🏖️ Benefits

• Remote work option • Equal opportunity employment • Reasonable accommodations for US & Puerto Rico applicants • Veteran and disability-inclusive employment practices

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