Clinical Research Associate II – Oncology

🔥 12 hours ago

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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 pipeline by striving for excellence in clinical research. • Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. • Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. • Considered as the primary point of contact for the investigative site. • High level of competency or experience in providing contextual information on the clinical trials. • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans. • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). • Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool. • Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. • Ensures preventative and corrective action plans are put into place as needed, to mitigate risk and promote compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred. • Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials. • Familiar with risk‐based monitoring approach, onsite and offsite monitoring. • Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. • Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. • Demonstrate strong cross-functional collaboration skills among internal and external stakeholders. • Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. • Advanced ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. • Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. • Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. • Acts with integrity in accordance with AbbVie code of business conduct and leadership values. • Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

🏖️ Benefits

• paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) to eligible employees • eligible to participate in short-term incentive programs

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