Clinical Research Associate I

🕒 June 3

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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 new advanced capabilities to drive industry leading performance. • 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. • Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects. • Customize site engagement strategy for assigned study (ies) under supervision. • Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. • Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. • 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. • 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.

🎯 Requirements

• Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred or experience or equivalent work experience. • Clinically related experience, preferably in clinical research coordinating or data management. • 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. • Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies. • Able to work collaboratively and cross functionally to develop and sustain working relationships. • Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. • Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site. • Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgement to address clinical site issues. • Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training. • 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

• Health insurance • Flexible work arrangements • Professional development