Clinical Research Associate 2

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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

• Monitor clinical investigative sites for AbbVie clinical studies • Ensure protocol execution, regulatory compliance, GCP/ICH adherence, SOP compliance, and quality standards • Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 studies • Oversee and influence site personnel to meet study objectives • Proactively manage sites and implement action plans to ensure compliance • Ensure regulatory inspection readiness at assigned clinical sites • Ensure quality and timely submission of study-site data, including safety-event reporting and follow-up • Protect study subjects through compliance with monitoring plans, SOPs, guidelines, and regulations • Train site personnel on protocols and regulatory requirements • Manage investigator payments according to contracts • Negotiate investigator/hospital agreements with stakeholders • Complete expense reports according to applicable guidelines • Identify, evaluate, and recommend potential investigators and clinical sites

🎯 Requirements

• Appropriate tertiary qualification in a health-related field preferred, such as Medical, Scientific, or Nursing • Minimum 2 years of clinically related experience • At least 1 year of independent monitoring experience • Experience independently conducting monitoring visits preferred • In-depth knowledge of therapeutic indications relevant to clinical trials • In-depth knowledge of clinical research regulations, ICH/GCP Guidelines, and applicable regulations • Strong planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to understand and follow work processes within the assigned function • Strong analytical and conceptual capabilities • Strong interpersonal and communication skills • Ability to address clinical site issues with appropriate guidance and initiate and communicate corrective action • Ability to use functional expertise and exercise good judgment • Demonstrated business ethics and integrity

🏖️ Benefits

• Remote work option • Equal opportunity employment • Reasonable accommodation for US & Puerto Rico applicants