Clinical Research Associate I

Company Overview: AbbVie

AbbVie is dedicated to discovering and delivering innovative medicines and solutions to address serious health issues and future medical challenges. We aim to make a remarkable impact on people's lives across key therapeutic areas including immunology, oncology, neuroscience, eye care, and our Allergan Aesthetics portfolio. Discover more about AbbVie at www.abbvie.com and follow us on social media.

About the Clinical Research Associate I Role

These Clinical Research Associate I positions are field-based/remote across various US locations, including California, Seattle, Oklahoma, Atlanta, the Northeast, and Southwest. In this role, you will contribute to advancing 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.

You will partner meaningfully and effectively with investigators and site staff, positioning AbbVie as the preferred choice in clinical trials. Your focus will be on site clinical research to ensure appropriate trial conduct, driving improvements in data integrity, compliance, overall study performance, and customer experience.

Key Responsibilities for Clinical Research Associate I

• Serve as the primary point of contact for investigative sites, providing contextual information on clinical trials, connecting stakeholders, and strengthening AbbVie's positioning.
• Under supervision, align, train, and motivate site staff and principal investigators on clinical trial program goals, protocol, and patient treatment principles, fostering a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure activities, adhering to the protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie SOPs, ensuring subject safety and data quality.
• Customize site engagement strategies for assigned studies under supervision, utilizing tools like the Customer Relationship Management (CRM) system to track progress and measure impact.
• Demonstrate a fundamental understanding of connecting study protocols, scientific principles, and clinical trial requirements to day-to-day execution. Evaluate and ensure effective recruitment and retention plans based on the patient disease journey.
• Develop solid knowledge of the therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
• Responsible for continuous proactive risk-assessment, in collaboration with the Central Monitoring team, to monitor clinical site activities, detecting early study performance or patient safety issues. Apply critical thinking to resolve site risk signals with a robust understanding of site processes to drive study execution.
• Implement preventative and corrective action plans as needed, to mitigate risk and promote compliance using a customer-centric approach.
• Identify, evaluate, and recommend new/potential investigators/sites under supervision and support from experienced CRAs.
• Ensure the quality of data submitted from study sites and the timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Maintain audit and regulatory inspection readiness at assigned clinical sites at all times. Manage investigator payments according to executed contract obligations, where applicable.

Qualifications

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred, or equivalent work experience.
• Clinically related experience, preferably in clinical research coordinating or data management.
• Knowledge of appropriate therapeutic area indications preferred, with the ability to understand and apply scientific concepts related to clinical trial conduct.
• Understanding of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Ability to work collaboratively and cross-functionally to develop and sustain working relationships.
• Demonstrated planning and organizational skills, with 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 site health.
• Capability to use functional expertise with appropriate guidance, apply critical thinking skills, and exercise good judgment to address clinical site issues.
• Strong interpersonal skills with excellent written, verbal, active listening, and presentation abilities, capable of establishing and leveraging site relationships and trusted partnerships through engagement, motivation, and training.
• Acts with integrity in accordance with the AbbVie code of business conduct and leadership values.
• A self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Key Skills/Competency

• Clinical Research
• GCP Guidelines
• ICH Guidelines
• Site Monitoring
• Protocol Compliance
• Data Integrity
• Patient Safety
• Therapeutic Area Knowledge
• Risk Assessment
• Stakeholder Engagement