Senior Clinical Research Associate

🔥 2 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $96.5k - $183.5k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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AbbVie

WebsiteLinkedInAll Job Openings

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, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. • Partners with study teams, AbbVie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the partner of 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. • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. • Responsible for activities as assigned by manager. • 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. • Generates and ensures effective recruitment and retention techniques/plans based on the patient disease journey. • Demonstrates ability to openly listen to and consider viewpoints to enhance outcomes. • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. • Manages investigator payments as per 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, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. • Familiar with risk‐based monitoring approach, onsite and offsite monitoring. • Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials. • Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. • Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders. • Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. • Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. • Superior 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 independently use functional expertise, 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)