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 the investigative site. • Provide trial context, connect stakeholders to investigative sites, and strengthen AbbVie’s clinical-trial partnerships. • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles. • Mentor and train junior CRAs and support local onboarding. • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring. • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards. • Develop and apply site-engagement strategies; gather local/site insights and track strategy impact. • Develop recruitment and retention techniques based on the patient disease journey. • Conduct continuous risk assessment with the Central Monitoring team to identify study-performance and patient-safety issues. • 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. • Participate in or lead global/local task forces and initiatives. • Perform additional activities assigned by the manager.

🎯 Requirements

• Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred • Minimum of 3 years of clinically related experience • Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials • Familiarity with risk-based monitoring, including onsite and offsite monitoring • Knowledge of therapeutic-area indications and ability to apply scientific concepts to clinical-trial conduct • 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 establish site relationships and trusted partnerships through engagement, motivation, and training • Ability to independently apply functional expertise, critical thinking, and sound judgment to clinical-site issues • Integrity in accordance with AbbVie’s code of business conduct and leadership values • Self-motivated focus 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