Clinical Research Associate II – Neuroscience

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

📋 Description

• Act as the main liaison for investigative sites.

• Supply relevant clinical trial details and facilitate connections between stakeholders and investigative sites.

• Align, train, and inspire site personnel and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Perform site assessments, training, routine monitoring, and site closure operations.

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

• Create and tailor site engagement strategies and monitor progress using CRM tools.

• Relate study protocols and scientific principles to the practical execution of clinical trials.

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

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

• Guide and train junior CRAs and assist in their professional growth.

• Engage in global/local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify, assess, and recommend investigators and sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contracts, when applicable.

⛳️ Requirements

• At least 1 year of clinically relevant experience.

• A minimum of 6 months of clinical research monitoring experience for investigational drug or device trials.

• Familiarity with risk-based monitoring, onsite monitoring, and offsite monitoring.

• Preferred knowledge of relevant therapeutic-area indications.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to thrive in a dynamic environment with multiple projects and deadlines.

• Proficiency in utilizing technology, tools, and resources for site support.

• Strong interpersonal, written, verbal, active listening, and presentation abilities.

• Ability to build site relationships and foster trusted partnerships through engagement, motivation, and training.

• Critical thinking and judgment skills for resolving clinical-site challenges.

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

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

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

🏝️ Benefits

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

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Opportunities for remote work.

• Commitment to equal opportunity for all applicants, including veterans and disabled individuals.

• Support for reasonable accommodations.