Clinical Research Associate II – Immunology

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

📋 Description

• Propel AbbVie’s clinical research initiatives by transforming scientific discoveries into therapeutic solutions while utilizing advanced capabilities.

• Act as the principal liaison for investigative sites.

• Provide context for clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Conduct evaluations of sites, training sessions, routine monitoring, and closure activities.

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

• Develop and tailor strategies for site engagement while utilizing CRM tools to track progress and assess impact.

• Support efficient patient recruitment and retention based on the patient disease journey.

• Acquire knowledge of the therapeutic area, clinical assets, clinical landscape, and patient journey.

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

• Participate in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team to identify issues related to study performance or patient safety.

• 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.

• Oversee investigator payments in accordance with contractual obligations when applicable.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• A minimum of 1 year of clinically related experience is required.

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

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

• Knowledge of relevant therapeutic area indications is preferred.

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

• Strong skills in cross-functional collaboration, planning, organization, interpersonal communication, writing, speaking, active listening, and presentations.

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

• Advanced capability to utilize technology, tools, and resources effectively.

• Competence in establishing site relationships and building trusted partnerships through engagement, motivation, and training.

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

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employment.

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