Clinical Research Associate II

🔥 41 minutes ago

🇨🇳 China – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 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 by striving for excellence in clinical research and leveraging advanced capabilities • Partner with investigators and site staff to establish meaningful and effective engagements • Serve as the primary 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, protocols and patient treatment principles • Conduct site evaluation, site training, routine monitoring and site closure activities • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards • Customize site engagement strategies and use CRM tools to report progress and measure impact • Connect study protocols, scientific principles and clinical trial requirements to day-to-day execution • Evaluate recruitment and retention techniques based on the patient disease journey • Develop therapeutic area, asset, clinical landscape and patient journey knowledge • Mentor and train less experienced CRAs and contribute to their development • Participate in global/local task forces and initiatives as assigned • 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 planned clinical studies • Ensure quality and timely submission of site data, 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

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience for investigational drug or device trials • Familiarity with risk-based monitoring approach, onsite and offsite monitoring • Knowledge of appropriate therapeutic area indications preferred • Ability to understand and apply scientific concepts to clinical trial conduct • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines • Advanced ability to leverage technology, tools and resources for customer-centric site support • Strong interpersonal, written, verbal, active listening and presentation skills • Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training • Ability to apply critical thinking and good judgment to clinical site issues • Integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated; focused on timely and quality outcomes in a fast-paced environment

🏖️ Benefits

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