Clinical Research Associate

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

📋 Description

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

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

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

• Execute site evaluations, training sessions, routine monitoring, and site closure activities.

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

• Develop and tailor site engagement strategies for designated studies.

• Collect site insights and utilize CRM tools to monitor progress and evaluate impact.

• Assist in the execution of clinical trials and ensure compliance with protocols.

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

• Enhance knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys.

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

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

• Detect and address site risk signals, implementing preventive or corrective action plans.

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

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as necessary.

⛳️ Requirements

• Bachelor's Degree in health-related fields (Medical, Scientific, Nursing) preferred.

• At least 1 year of clinically related experience, with a minimum of 6 months in clinical research monitoring of investigational drug or device trials.

• Familiarity with risk-based monitoring strategies and both onsite and off-site monitoring.

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration, planning, and organization.

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

• Capability to leverage technology, tools, and resources to support sites.

• Excellent written, verbal, active listening, presentation, interpersonal, and relationship-building abilities.

• Competency in applying critical thinking and sound judgment to clinical site challenges.

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

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

• Regular driving required and eligibility to operate a company vehicle.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Eligibility for a company vehicle, subject to relevant policies and procedures.