Senior Clinical Research Associate

đŸ”„ 12 hours ago

đŸ‡čđŸ‡Œ Taiwan – Remote

⏰ Full Time

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

đŸ„ Healthcare

đŸ’Œ 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 audit and inspection readiness of assigned sites ‱ Advise on pre-audit activities for GCP requirements ‱ Prepare and follow up on site audits/inspections and provide 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 globally when assigned ‱ Support onboarding, consolidate lessons learned, define best-practice training curricula, and maintain awareness of upcoming changes ‱ Serve as key point of contact in country/district for assigned studies when assigned ‱ Update Impact/Tesla with country-level information and planning timelines when assigned ‱ Act as global representative for one or more studies when assigned ‱ Conduct remote data review of assigned sites/studies according to applicable plans, SOPs/WIs, timelines, and objectives when assigned ‱ Provide ongoing feedback on investigator/site performance ‱ Build professional and collaborative relationships with peers and site monitors

🎯 Requirements

‱ Bachelors 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 ‱ Adherence to federal and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans

đŸ–ïž 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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