Clinical Research Associate II – Eyecare, Aesthetics, Specialty

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

📋 Description

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

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

• Provide relevant information on clinical trials and facilitate connections between stakeholders and investigative sites.

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

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

• Guarantee adherence to protocols, monitoring plans, applicable regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, and quality standards.

• Tailor site engagement strategies for the studies assigned.

• Collect local and site-specific insights and utilize CRM tools to report, track, and assess engagement progress.

• Support the daily execution of clinical trials by applying knowledge of protocols, scientific principles, and clinical trial processes.

• Assess and ensure effective strategies for patient recruitment and retention.

• Develop a strong understanding of therapeutic areas, assets, clinical landscapes, and patient journeys to assist in recruitment and ensuring protocol adherence.

• Mentor and train less experienced Clinical Research Associates (CRAs) and contribute to their professional growth.

• Take part in global or local task forces and initiatives as assigned.

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

• Supervise clinical site activities to identify study performance or patient safety concerns.

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

• Identify, evaluate, and recommend potential investigators and sites.

• Ensure the timely and quality submission of site data, including safety-event reporting and follow-ups.

• Maintain readiness for audits and regulatory inspections at assigned clinical sites.

• Oversee investigator payments according to executed contract obligations, as applicable.

⛳️ Requirements

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

• At least 1 year of clinically related experience is required.

• Minimum of 6 months of clinical research monitoring experience with investigational drug or device trials.

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

• Knowledge of relevant therapeutic area indications is preferred.

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

• Strong collaboration skills across various functions.

• Excellent planning and organizational abilities.

• Capability to work effectively and efficiently in a fast-paced environment with multiple projects and deadlines.

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

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

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

• Capacity to apply critical thinking and sound judgment to resolve clinical site issues.

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

• Self-motivated with a focus on delivering high-quality outcomes promptly in a dynamic environment.

🏝️ Benefits

• Paid time off, which includes vacation, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Commitment to equal opportunity employment.

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