Senior Clinical Research Associate

đŸ”„ 0 minutes ago

đŸ‡”đŸ‡± Poland – 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

‱ Advance AbbVie's clinical research pipeline by striving for excellence in clinical research ‱ Partner with study teams, internal R&D stakeholders, investigators and site staff ‱ Serve as the primary Sponsor point of contact for the investigative site ‱ Provide contextual clinical-trial information and connect stakeholders with investigative sites ‱ Motivate and align the monitoring community through leadership and mentorship ‱ Train and motivate site staff and principal investigators on trial goals, protocol and patient-treatment principles ‱ Support, guide and mentor junior personnel on Site Management activities ‱ Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring ‱ Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards ‱ Customize site-engagement strategies and track progress and impact using site-engagement tools ‱ Apply scientific principles and clinical-trial requirements to day-to-day trial execution ‱ Generate and ensure effective patient recruitment and retention techniques and plans ‱ Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge ‱ Mentor and train less experienced CRAs and support local onboarding ‱ Participate in or lead global/local task forces and initiatives ‱ Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or 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 data quality and timely submission, including safety-event reporting and follow-up ‱ Maintain audit and regulatory inspection readiness at assigned clinical sites ‱ Manage investigator payments according to executed contract obligations, as applicable

🎯 Requirements

‱ Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred ‱ Minimum of 3 years of clinically related experience ‱ Preferably 2 years in independent clinical research monitoring of investigational drug or device trials ‱ Familiarity with risk-based monitoring approach, onsite and offsite monitoring ‱ Knowledge of appropriate therapeutic area indications and scientific concepts related to clinical trials ‱ Superior 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 ‱ Superior interpersonal, written, verbal, active listening and presentation skills ‱ Ability to independently use functional expertise, critical thinking and good judgement 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 ‱ Excellent command of English and local language

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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