Senior Clinical Research Associate

Role Overview

• Advance AbbVie’s pipeline by striving for excellence in clinical research
• 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
• Considered as the Primary Sponsor Point of contact for the investigative site
• Advanced level of competency or experience in providing contextual information on the clinical trials
• Ability to motivate and align monitoring community through leadership and mentorship
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities
• Ensure safety and protection of study subjects
• Gather local/site insights and utilize site engagement tools to report/track progress and measure impact of that strategy
• Ensures quality of data submitted from study sites and assures timely submission of data
• Manage investigator payments as per executed contract obligations, as applicable

Requirements

• Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
• 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.

Tech Stack

• Google Cloud Platform

Benefits

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