Clinical Research Associate II

🔥 16 hours ago

🇵🇷 Puerto Rico – Remote

💵 $61k - $120.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 Ghost score 0%

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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 point of contact for investigative sites • Provide clinical-trial context, connect stakeholders with investigative sites, and strengthen AbbVie's positioning • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Conduct site evaluation, site 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 for assigned studies • Gather local and site insights and use CRM tools to track progress and measure impact • Connect study protocols and scientific principles to day-to-day trial execution • Evaluate and ensure recruitment and retention techniques 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 and local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team to detect study-performance and patient-safety issues • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate, and recommend investigators and sites for clinical studies • 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 contract obligations, as applicable

🎯 Requirements

• Bachelor's Degree in health related disciplines (Medical, Scientific, Nursing) preferred • Previous experience as CRA is required, performing investigation monitoring and similar functions • Minimum of 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials • Familiarity with risk-based monitoring approach, onsite and off-site monitoring • Knowledge of appropriate therapeutic area indications preferred • 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 in a dynamic environment with competing projects and deadlines • Advanced ability to leverage technology, tools, and resources • Strong interpersonal skills and excellent written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training • Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues • Integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes • Regular driving and eligibility to operate a company vehicle, subject to AbbVie policies and procedures

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical, dental, and vision insurance • 401(k) • Short-term incentive programs • Company vehicle eligibility, subject to applicable policies and procedures

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