Senior Clinical Research Associate

🔥 0 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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AbbVie

WebsiteLinkedInAll Job Openings

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, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards • Customize site engagement strategies and track progress, impact and local/site insights • Apply scientific principles, clinical trial requirements and therapeutic-area knowledge to trial execution • Develop recruitment and retention techniques 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 detect study performance or patient safety issues • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate and recommend investigators and sites for clinical studies • Ensure quality and timely submission of site data, including 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 • Perform additional activities assigned by the manager

🎯 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 appropriate therapeutic area indications and ability to understand and 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 • 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 • Excellent written, verbal, active listening and presentation 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 • Acts with integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Full-time availability

🏖️ Benefits

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

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