Clinical Research Associate I

🔥 0 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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 Sponsor point of contact for investigative sites • Provide contextual information on clinical trials and connect stakeholders with investigative sites • Align, train and motivate site staff and principal investigators on clinical trial program goals, protocols and patient treatment principles • Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure activities • Ensure compliance with protocols, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards • Customize site engagement strategies and gather local/site insights • Report and track site engagement progress and measure strategy impact • Connect study protocols, scientific principles and clinical trial requirements to day-to-day trial execution • Evaluate recruitment and retention techniques based on the patient disease journey • Develop therapeutic area, asset, clinical landscape and patient journey knowledge • 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 • Ensure quality and timely submission of study data and safety event reporting • Maintain audit and regulatory inspection readiness at assigned clinical sites • Manage investigator payments according to executed contract obligations

🎯 Requirements

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy) • Clinically related experience in clinical research coordinating or data management preferred • Knowledge of appropriate therapeutic area indications preferred • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies • Ability to work collaboratively and cross functionally • Planning and organizational skills; ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools and resources • Strong 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 judgement to address clinical site issues • Acts with integrity in accordance with AbbVie code of business conduct and leadership values • Self-motivated and focused on delivering timely and quality outcomes in a fast-paced environment

🏖️ Benefits

• Full-time employment • Equal opportunity employment • Employer commitment to operating with integrity, driving innovation, transforming lives and serving the community

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