Senior Clinical Research Associate

🔥 1 hour ago

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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

• Act as the primary Sponsor point of contact for investigative sites and connect stakeholders • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring • Ensure compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs, protocols, monitoring plans, and quality standards • Develop and execute site engagement strategies; gather site insights and track strategy impact • Connect study protocols and scientific principles to daily clinical trial execution • Evaluate and ensure recruitment and retention plans based on the patient disease journey • Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance • Mentor and train less experienced CRAs and contribute to their development • Participate in global/local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team and identify study performance or patient safety issues • Resolve site risk signals and implement preventive and corrective action plans • Identify and recommend potential investigators and sites for planned clinical studies • Ensure data quality, timely data submission, safety-event reporting, and follow-up by site personnel • Maintain audit and regulatory inspection readiness at assigned clinical sites • Manage investigator payments according to contract obligations, where applicable • Report adverse events within 24 hours according to AbbVie policies and procedures • Participate in WHS programs and promote a safe work environment • Maintain compliance with AbbVie codes of conduct, training, ethics, and integrity requirements • Perform ad hoc administrative duties as requested

🎯 Requirements

• Appropriate tertiary qualification in a health-related discipline such as Medical, Scientific, Pharmacy, or Nursing is preferred • Minimum 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 onsite/offsite monitoring • Knowledge of relevant 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, with 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 through engagement, motivation, and training • Ability to independently apply functional expertise, critical thinking, and judgment to clinical-site issues • Ability to act with integrity under AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment • Flexibility to occasionally participate in business meetings outside standard hours

🏖️ Benefits

• Remote work arrangement • Flexible and accessible hiring process • Flexible workplace • Support for accessibility requirements • Inclusive and supportive workplace • Right to disconnect outside working hours, subject to reasonable exceptions