Senior Clinical Research Associate

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 • Serve as the primary sponsor point of contact for investigative sites • Partner with study teams, internal R&D stakeholders, investigators, and site staff • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Mentor and support junior CRAs and support local onboarding • 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 • Customize site engagement strategies and track progress and impact • Support recruitment and retention techniques based on the patient disease journey • Conduct continuous risk assessment with the Central Monitoring team • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend investigators and clinical sites • Ensure data quality, timely data submission, and appropriate safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contract obligations • Participate in or lead global and 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 • 2 years preferable in independent clinical research monitoring of 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 for customer-centric site support • 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 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