Senior Clinical Research Associate

🔥 43 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 oncology clinical research pipeline and support innovative medicines and solutions • 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 and CRAs on site-management activities • Conduct site evaluation, site training, routine onsite/offsite 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 • Develop recruitment and retention techniques based on the patient disease journey • Participate in or lead global/local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team and address site risk signals • Implement preventative and corrective action plans to mitigate risk and promote compliance • 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

• Minimum of 3 years of clinically related experience • Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials • Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Familiarity with risk-based monitoring and onsite/offsite monitoring • Knowledge of therapeutic-area indications and scientific concepts relevant 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 manage competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Superior interpersonal, written, verbal, active listening, and presentation skills • Ability to independently address clinical site issues using functional expertise, critical thinking, and judgment • Integrity consistent with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, 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