Senior Clinical Research Associate

🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 and support the development of innovative medicines. • Serve as the primary sponsor point of contact for investigative sites. • Provide contextual clinical trial information and connect study stakeholders with investigative sites. • Align, train and motivate site staff and principal investigators on trial goals, protocols and patient treatment principles. • Mentor and support junior personnel and CRAs 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. • Gather local and site insights to improve engagement and study performance. • Develop recruitment and retention techniques based on the patient disease journey. • Participate in or lead global and local task forces and initiatives. • Perform 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.

🎯 Requirements

• Minimum of 3 years of clinically related experience. • Preferably 2 years of independent clinical research monitoring experience involving investigational drug or device trials. • Familiarity with risk-based monitoring and on-site/off-site monitoring. • Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct. • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. • Advanced communication and cross-functional collaboration skills. • Strong planning and organizational skills; ability to manage competing projects and deadlines. • Ability to leverage technology, tools and resources to provide customer-centric site support. • Excellent written, verbal, active listening and presentation skills. • Ability to establish site relationships and trusted partnerships through engagement, motivation and training. • Ability to independently apply functional expertise, critical thinking and good judgment to clinical site issues. • Integrity in accordance with AbbVie’s code of business conduct and leadership values. • Self-motivated approach focused on timely, quality outcomes in a fast-paced environment.

🏖️ Benefits

• Remote work option • Equal opportunity employment • Commitment to operating with integrity, driving innovation, transforming lives and serving the community