Senior Clinical Research Associate

🔥 36 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Logo of AbbVie

AbbVie

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

• Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including study start-up, execution, and close-out • Conduct and oversee monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports • Anticipate and identify site issues affecting timelines and develop alternative solutions • Maintain current clinical trial management systems with site-specific information • Provide local regulatory and legal requirement expertise • Ensure timely payment execution for assigned sites/studies according to clinical study agreements and local requirements • Ensure adherence to federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards • Stay current on evolving local regulations, guidelines, and policies • Ensure audit and inspection readiness of assigned sites • Advise on pre-audit GCP activities and prepare/follow up on site audits and inspections, including input into CAPA preparation • Coach and mentor CRAs and provide input into their development • Serve as country point of contact for CROs when assigned • Participate in or lead global/local task forces and initiatives • Identify training needs and standardize/facilitate training solutions for SMM monitors when assigned • Support onboarding, consolidate lessons learned, develop best-practice training curricula, and maintain awareness of upcoming changes • Serve as a country/district study contact and update country-level information in Impact/Tesla when assigned • Act as global representative for assigned studies when assigned • Conduct remote data review of assigned sites/studies according to IDRP, Monitoring Plan, SOP/WI, timelines, and objectives when assigned • Provide ongoing feedback on investigator/site performance • Build professional and collaborative relationships with peers and site monitors

🎯 Requirements

• Bachelor's or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred • Minimum 5 years of site monitoring experience • Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making • Excellent interpersonal skills with the ability to communicate persuasively and with clarity • Flexibility and adaptability to changing requirements • Resourcefulness and creativity • Demonstrated proactive and positive team player • Strong planning and organizational skills • High level of flexibility in a dynamic environment with competing projects and deadlines • Demonstrated business ethics and integrity

🏖️ Benefits

• Employees can work remotely • Equal opportunity employer • Commitment to operating with integrity, driving innovation, transforming lives, and serving the community

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