Clinical Research Associate II

This is a fully remote position, open to applicants in Puerto Rico, +1 more country.

📋 Description

• Propel AbbVie’s clinical research pipeline while facilitating innovative medicines and solutions.

• Act as the main liaison for investigative sites.

• Provide context for clinical trials and connect stakeholders with investigative sites.

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

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

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

• Create and tailor site engagement strategies for assigned studies.

• Collect local and site insights and utilize CRM tools to track progress and assess impact.

• Support the execution of clinical trials by applying protocol, scientific, and clinical trial expertise.

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

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

• Mentor and train junior CRAs and contribute to their professional development.

• Engage in global or local task forces and initiatives.

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

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

• Identify, evaluate, and recommend investigators and sites for upcoming clinical studies.

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

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

• Manage investigator payments in accordance with executed contract obligations, as applicable.

⛳️ Requirements

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

• Minimum of 1 year of experience in a clinically related role.

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

• Familiarity with risk-based monitoring techniques, including both onsite and off-site monitoring.

• Knowledge of relevant therapeutic area indications is preferred.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities; capable of managing multiple projects and deadlines.

• Ability to utilize technology, tools, and resources for customer-focused site support.

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

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

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

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

• Self-driven and focused on achieving timely, high-quality results in a dynamic environment.

• Frequent to continuous computer usage (50% or more of the workday).

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Equal opportunity employer.

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