Clinical Research Associate II

This is a fully remote position, open to applicants in Florida, +1 more state.

📋 Description

• Propel AbbVie’s clinical research pipeline by facilitating the execution of clinical trials.

• Act as the main liaison for investigative sites.

• Offer clinical trial context and connect stakeholders with investigative sites.

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

• Conduct evaluations of sites, provide training, execute routine monitoring, and oversee site closure activities.

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

• Formulate and tailor site engagement strategies while tracking progress using CRM tools.

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

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

• Mentor and train junior CRAs, contributing to their professional development.

• Engage in global/local task forces and initiatives.

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

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

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

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as relevant.

⛳️ Requirements

• A minimum of 1 year of clinically relevant experience.

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

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

• Preferred knowledge of applicable therapeutic area indications.

• Capability to comprehend and apply scientific concepts in clinical trial execution.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

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

• Exceptional interpersonal, written, verbal, active listening, and presentation skills.

• Ability to establish and cultivate site relationships and trusted partnerships.

• Capability to apply critical thinking and sound judgment to clinical site challenges.

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

• Self-motivated with a focus on delivering timely, high-quality outcomes.

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Remote work option available.

• Equal opportunity employer benefits and reasonable accommodation support.