Clinical Research Associate II

Role Overview

• 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, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conduct site evaluation, training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, ensuring safety and protection of study subjects.
• 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 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.
• Mentor and train less experienced CRAs on various aspects of work and provide 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.
• Identify, evaluate and recommend 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.

Tech Stack

• Google Cloud Platform

Benefits

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