Clinical Research Associate I

Role Overview

• This is a remote / field based position requiring residence in the San Francisco or Los Angeles area and willingness to travel for site visits.
• Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for patients and leveraging new advanced capabilities to drive industry leading performance.
• Considered as the primary 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 under supervision 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, and site closure monitoring activities under supervision, in compliance with protocol and monitoring plans and in 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 the Central Monitoring team to monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.

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.
• 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