Clinical Research Associate I – Immunology

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

📋 Description

• Propel AbbVie’s clinical research initiatives by ensuring excellence in clinical research.

• Act as the main point of contact for investigative sites.

• Provide context for clinical trials and connect stakeholders with investigative sites.

• Align, train, and inspire site staff and principal investigators under supervision.

• Conduct site assessments, training, routine monitoring, and closure activities under supervision.

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

• Tailor site engagement strategies and monitor progress using CRM tools.

• Link study protocols, scientific principles, and clinical-trial requirements to daily operations.

• Assess recruitment and retention strategies based on the patient's disease journey.

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

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

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

• Identify, evaluate, and recommend investigators and sites under supervision.

• Ensure quality and timely submission of site data and safety-event reports.

• Maintain readiness for audits and regulatory inspections.

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

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (Medical, Scientific, Nursing) is preferred, or equivalent work experience.

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

• Familiarity with therapeutic-area indications is preferred.

• Understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Ability to work collaboratively across various functions.

• Strong planning and organizational skills; capable of managing multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources.

• Critical thinking and sound judgment for addressing clinical site challenges.

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

• Ability to build and leverage relationships with sites through engagement, motivation, and training.

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

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

• Capability to work remotely.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in long-term incentive programs.

• Commitment to equal opportunity employment.

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