Senior Clinical Research Associate – Oncology

🔥 18 hours ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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 and support innovative medicines and solutions • Partner with study teams, internal R&D stakeholders, investigators, and site staff • Serve as a 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 • Support, guide, and mentor junior personnel and CRAs • Conduct site evaluation, site training, routine onsite and offsite monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards • Develop and apply site engagement strategies and track their impact • Support recruitment and retention techniques based on the patient disease journey • Develop knowledge of the therapeutic area, asset, clinical landscape, and patient journey • Participate in or lead global and local task forces and initiatives • Perform continuous risk assessment with the Central Monitoring team • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend potential investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to contract obligations, where applicable

🎯 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 involving investigational drug or device trials • Familiarity with risk-based monitoring, onsite and offsite monitoring • Knowledge of therapeutic area indications and scientific concepts related to clinical trials • 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 work effectively in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools, and resources • Excellent written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships and trusted partnerships • Ability to independently address clinical site issues using functional expertise, critical thinking, and good judgment • Acts with integrity in accordance with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Willingness to travel 75% of the time

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Remote work option