Clinical Research Associate II

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $84.5k - $162k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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

• Serve as the primary point of contact for investigative sites • Provide contextual information about clinical trials and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on clinical trial goals, protocols, and patient treatment principles • Conduct site evaluation, site training, routine monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards • Customize site engagement strategies for assigned studies • Gather site insights and use CRM tools to report and track progress and measure impact • Connect study protocols and scientific principles to day-to-day clinical trial execution • Evaluate 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 provide development input • Participate in global/local task forces and initiatives • 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 sites for planned clinical studies • Ensure quality and timely submission of site data, safety-event reporting, and follow-up • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contract obligations, as applicable • Travel to clinical research sites in Southern California

🎯 Requirements

• Must reside in Southern California • Bachelor’s degree or equivalent degree; health-related degree preferred (e.g., Medical, Scientific, Nursing, Pharmacy) • 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, including onsite and offsite monitoring • 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 in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Strong interpersonal skills • Excellent written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships through engagement, motivation, and training • Ability to apply critical thinking and good judgment to clinical site issues • Ability to act with integrity under AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment • Willingness to travel for site visits

🏖️ Benefits

• Paid time off (vacation, holidays, sick) • Medical insurance • Dental insurance • Vision insurance • 401(k) • Short-term incentive programs • Equal opportunity employer • Reasonable accommodations for US & Puerto Rico applicants