Senior Clinical Research Associate

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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 clinical-trial context and connect study stakeholders with investigative sites • Align, train, motivate, and mentor site staff and principal investigators on trial goals, protocols, and treatment principles • Support and mentor junior personnel and CRAs on site-management activities • Conduct site evaluation, training, routine on-site and off-site monitoring, and site-closure monitoring • Customize site-engagement strategies, gather site insights, and track strategy progress and impact • 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 and collaborate with Central Monitoring to identify study-performance and patient-safety issues • Resolve site-risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend potential investigators and clinical-trial sites • Ensure data quality, timely data submission, safety-event reporting, and follow-up • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to executed contracts, as applicable

🎯 Requirements

• Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum 3 years of clinically related experience • Preferably 2 years independently monitoring investigational drug or device trials • Familiarity with risk-based monitoring and on-site/off-site monitoring • Knowledge of relevant therapeutic-area indications and scientific concepts in clinical-trial conduct • 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 • Excellent written, verbal, active-listening, presentation, interpersonal, and relationship-building skills • Ability to independently apply functional expertise, critical thinking, and good judgment to clinical-site issues • Integrity aligned with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment