Clinical Research Associate II – Neurology

This is a fully remote position, open to applicants in Louisiana, +2 more states.

📋 Description

• Propel AbbVie’s clinical research pipeline while supporting innovative medicines and solutions.

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

• Provide relevant information on clinical trials and link stakeholders with investigative sites.

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

• Conduct evaluations, training, routine monitoring, and closure assessments for sites.

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

• Create and tailor site engagement strategies for assigned studies.

• Collect insights from sites and utilize CRM tools to document and track progress while measuring impact.

• Relate study protocols, scientific principles, and clinical trial requirements to daily execution of trials.

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

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

• Mentor and train less experienced CRAs, contributing to their growth.

• Engage in global or local task forces and initiatives.

• Perform continuous risk assessments with the Central Monitoring team.

• Oversee clinical-site activities regarding study performance and patient safety concerns.

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

• Identify, assess, and recommend investigators and clinical sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments according to executed contractual obligations.

⛳️ Requirements

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

• A minimum of 1 year of experience in a clinically related role.

• At least 6 months of experience in clinical research monitoring of investigational drug or device trials.

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

• Preferred knowledge of therapeutic area indications.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational capabilities.

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

• Advanced proficiency in leveraging technology, tools, and resources.

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

• Capability to build and leverage site relationships and trusted partnerships.

• Ability to apply functional expertise, critical thinking, and sound judgment to resolve clinical site issues.

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

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

• Willingness to travel 75% of the time.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Travel opportunities (75% of the time).

• Equal opportunity employer; encourages applications from veterans and individuals with disabilities.

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