Clinical Research Associate I

This is a fully remote position, open to applicants in California.

📋 Description

• Act as the main liaison for investigative sites and offer relevant information regarding clinical trials.

• Facilitate connections between stakeholders and investigative sites to enhance AbbVie’s presence.

• Align, train, and inspire site staff and principal investigators on study objectives, protocols, and principles of patient treatment.

• Perform site evaluations, training, routine monitoring, and closure activities with oversight.

• Ensure adherence to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and standards of clinical research quality.

• Tailor site engagement strategies and utilize CRM tools to track progress and assess impact.

• Relate study protocols, scientific principles, and clinical trial requirements to everyday execution tasks.

• Assess and assist in effective patient recruitment and retention strategies.

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

• Conduct ongoing risk assessments with the Central Monitoring team to pinpoint study performance and patient safety concerns.

• Address site risk signals and implement preventative and corrective action plans.

• Identify, evaluate, and recommend investigators and clinical sites with supervision.

• Guarantee the quality and timely submission of site data, including safety-event reporting and follow-ups.

• Sustain audit and regulatory inspection readiness at designated sites.

• Oversee investigator payments in accordance with executed contract obligations, when applicable.

⛳️ Requirements

• Preferred tertiary qualification in health-related fields (Medical, Scientific, Nursing) or equivalent professional experience.

• Experience in clinical settings, ideally in clinical research coordination or data management.

• Familiarity with therapeutic area indications is preferred.

• Capability to comprehend and apply scientific principles to the execution of clinical trials.

• Knowledge of local regulatory and legal standards, ICH/GCP Guidelines, and relevant policies.

• Ability to collaborate effectively across functions and teams.

• Strong organizational and planning skills to navigate a dynamic environment with competing priorities and deadlines.

• Proficiency in utilizing technology, tools, and resources for site support focused on customer needs.

• Competence in applying functional expertise, critical thinking, and sound judgment to clinical site challenges.

• Excellent written, verbal, active listening, and presentation skills.

• Skill in establishing and leveraging relationships with sites through engagement, motivation, and training.

• Integrity that aligns with AbbVie’s code of business conduct and leadership principles.

• Self-driven and focused on achieving timely, quality outcomes.

• Willingness and capacity to travel 75% of the time.

• Preference for candidates located in the Southwest, Southeast, and Northeast regions, especially near a major airport.

🏝️ Benefits

• Paid time off (including vacation, holidays, and sick leave).

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in short-term incentive programs.

• Option for remote work.

• Commitment to equal employment opportunities.

• Reasonable accommodations available for applicants in the US & Puerto Rico.