Clinical Research Associate

🔥 1 hour ago

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Logo of AbbVie

AbbVie

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 • Act as the primary point of contact for investigative sites • Provide clinical-trial context and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles • Conduct site evaluation, training, routine monitoring, and site-closure activities in compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards • Develop and customize site-engagement strategies and track progress using CRM tools • Connect study protocols and scientific principles to day-to-day clinical-trial execution • Evaluate recruitment and retention techniques based on the patient disease journey • Build 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 or local task forces and initiatives • Conduct continuous risk assessment and collaborate with Central Monitoring to detect study-performance or patient-safety issues • Implement preventative and corrective action plans to mitigate risk and promote compliance • Identify, evaluate, and recommend investigators and clinical sites • 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 contracts, where applicable

🎯 Requirements

• Appropriate tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience involving investigational drug or device trials • Familiarity with risk-based monitoring and onsite/offsite monitoring • Knowledge of therapeutic-area indications preferred • Ability to understand and apply scientific concepts to clinical-trial conduct • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills; ability to work effectively amid competing projects and deadlines • Advanced ability to leverage technology, tools, and resources • Strong interpersonal, written, verbal, active-listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Ability to apply critical thinking and judgment to clinical-site issues • Integrity consistent with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes

🏖️ Benefits

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

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