Senior Clinical Research Associate

🔥 12 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

• Advance AbbVie's clinical research pipeline in the immunology therapy area • Partner with study teams, internal R&D stakeholders, investigators and site staff • Serve as the primary sponsor point of contact for the investigative site • Provide contextual information on clinical trials and connect stakeholders with investigative sites • Align, train and motivate site staff and principal investigators on trial goals, protocol 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, GCPs, ICH Guidelines, SOPs and quality standards • Customize site engagement strategies and use site engagement tools to track progress and measure impact • Support recruitment and retention techniques and plans based on the patient disease journey • Develop knowledge of the therapeutic area, asset, clinical landscape and patient 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 assessment in collaboration with the Central Monitoring team • Identify and 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 superior cross-functional collaboration skills • Superior 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 to provide customer-centric support • Superior interpersonal skills, including written, verbal, active listening and presentation skills • Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training • Ability to independently use functional expertise, critical thinking and good judgment to address clinical site issues • Acts with integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on delivering timely and quality outcomes in a fast-paced environment

🏖️ Benefits

• Employees can work remotely • Equal opportunity employer • AbbVie is committed to operating with integrity, driving innovation, transforming lives and serving the community

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