Clinical Research Associate I

The Clinical Research Associate I will advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry leading performance. They partner with study teams, Abbvie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. The CRA I will also 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.

Responsibilities

Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie's positioning; Align, train and motivate site staff and principal investigator on the goals of the clinical trial program, protocol, and patient treatment principles; Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure activities in compliance with the protocol, monitoring plans, applicable regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards, ensuring safety and protection of study subjects; Customize site engagement strategy for assigned study (ies), gather local/site insights and use site engagement tracking tools to report/track progress and measure impact; Connect the study protocol, scientific principles and clinical trial requirements to day-to-day clinical trial execution, and ensure effective recruitment and retention techniques/plans based on the patient's disease journey; Develop knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and protocol compliance; Perform continuous risk-assessment and, in collaboration with Central Monitoring team, monitor clinical site activities to detect early study performance or patient safety issues; Resolve site risk signals and put preventative and corrective action plans in place to mitigate risk and promote compliance; Identify, evaluate and recommend new/potential investigators/sites; Ensure quality of data submitted from study sites, timely data submission, and appropriate reporting and follow-up for all safety events; Ensure audit and regulatory inspection readiness at assigned clinical sites; Manage investigator payments as per executed contract obligations, as applicable

Requirements

Bachelor's degree or equivalent degree; Knowledge of 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; 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 individuals focused on delivering timely and quality outcomes in a fast-paced environment

Nice to have

Bachelor's degree in a health-related field preferred (e.g. Medical, Scientific, Nursing, Pharmacy); Clinically related experience, in clinical research coordinating or data management preferred; Knowledge of appropriate therapeutic area indications preferred, with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials