Clinical Research Associate II

About the role

AbbVie is looking for a Clinical Research Associate II in San Juan to advance its pipeline through high-quality clinical research. The associate acts as the main point of contact for the investigative site, partners with the investigator and site staff, and focuses on site clinical research that improves data integrity, compliance, study performance and customer experience.

Key responsibilities

• Align, train and motivate site staff and the principal investigator on the trial goals, protocol and patient treatment principles.
• Conduct site evaluations, training, routine monitoring and site closure monitoring in line with GCPs, ICH guidelines, AbbVie SOPs and quality standards, protecting study subjects.
• Customize site engagement strategies, gather local insights and track progress with CRM tools.
• Evaluate recruitment and retention plans and recommend potential investigators and sites.
• Ensure quality and timeliness of site data, including reporting and follow-up on safety events, and maintain audit and regulatory inspection readiness.
• Manage investigator payments as per contract obligations.
• Proactively assess risks, work with the Central Monitoring team to spot early study or safety issues, and set up corrective actions.
• Mentor less experienced CRAs and take part in task forces and initiatives as assigned.

Required profile

• Bachelor's degree in a health-related discipline (medical, scientific, nursing) preferred.
• Previous experience as a CRA performing investigation monitoring and similar functions.
• At least 1 year of clinically related experience, including 6 months in clinical research monitoring of investigational drug or device trials.
• Familiarity with risk-based monitoring, on-site and off-site monitoring, and local regulatory and legal requirements.
• Eligibility to drive a company vehicle regularly, subject to AbbVie policies.

Required skills

• Knowledge of ICH/GCP guidelines and applicable policies.
• Strong cross-functional collaboration, planning and organizational skills.
• Excellent written, verbal and presentation skills, with strong interpersonal abilities.
• Ability to use technology and tools to support site customers.

What we offer

• Paid time off (vacation, holidays, sick leave).
• Medical, dental and vision insurance and a 401(k) for eligible employees.
• Eligibility for short-term incentive programs.