Clinical Research Associate I

About the role

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

• Serve as the primary Sponsor point of contact for the investigative site, providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning.
• Align, train, and motivate site staff and principal investigators with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership.
• Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, in compliance with the protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• Customize site engagement strategy for assigned study(ies) with support as needed; gather local/site insights and utilize site engagement tracking tools to report/track progress and measure impact of that strategy.
• Demonstrate fundamental competency connecting the study protocol, scientific principles, and clinical trial requirements to day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient's disease journey.
• Develop solid knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
• Perform continuous risk assessment proactively, and in collaboration with the Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Think critically to resolve site risk signals while maintaining robust understanding of site processes to drive study execution.
• Ensure preventative and corrective action plans are put in place as needed to mitigate risk and promote compliance using a customer-centric approach.
• Identify, evaluate, and recommend new/potential investigators/sites with support as needed from more experienced Site Monitors.
• Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensure audit and regulatory inspection readiness at all assigned clinical sites.
• 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).
• Clinically related experience in clinical research coordinating or data management preferred.

Qualifications

• Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

Skills

• Ability to work collaboratively and cross-functionally to develop and sustain working relationships.
• Strong 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 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 judgment to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated with focus on delivering timely and quality outcomes in a fast-paced environment.