Clinical Research Associate II

🕒 April 21

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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

• Considered as the primary Sponsor point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. • Aligns, trains and motivates the site staff and principal investigator with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, 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) with support as needed. Gather local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy. • Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. • 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. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. 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 with support as needed from more experienced Site Monitors. • 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. • Ensures audit and regulatory inspection readiness at assigned clinical site at all times. • 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 or experience or equivalent work experience. • Clinically related experience, in clinical research coordinating or data management preferred. • 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. • 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 • Professional development opportunities