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

• Advance AbbVie's clinical research pipeline by supporting clinical trials and translating science into medicine. • 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. • Mentor and support junior CRAs on site management activities and clinical research work. • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring. • Ensure trial conduct complies with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards. • Develop and execute customized site engagement strategies; gather site insights and track strategy impact. • Support recruitment and retention plans 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 identify study performance and 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 contract obligations, where applicable.

🎯 Requirements

• Minimum of 3 years of clinically related experience; 2 years preferably in independent clinical research monitoring of investigational drug or device trials. • Appropriate tertiary qualification in a health-related discipline such as Medical, Scientific, Pharmacy, or Nursing is preferred, not required. • Familiarity with risk-based monitoring and on-site/off-site monitoring. • Knowledge of therapeutic-area indications and ability to apply scientific concepts 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. • 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 aligned with AbbVie’s code of business conduct and leadership values. • Self-motivated approach focused on timely, quality outcomes in a fast-paced environment.

🏖️ Benefits

• Innovative work culture • Professional development • Paid time off: vacation, holidays, personal days, and volunteer days • Employee stock purchase • Wellness spending account • Flexible health insurance • Retirement savings programs • Bonus plan