Clinical Research Associate II

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

📋 Description

• Act as the main liaison for investigative sites.

• Offer contextual information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

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

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

• Create and tailor site engagement strategies.

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

• Assist in the execution of clinical trials while linking protocols and scientific principles to daily operations.

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

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

• Mentor and train junior Clinical Research Associates (CRAs).

• Participate in global or local task forces and initiatives.

• Perform ongoing risk assessments and collaborate with Central Monitoring to pinpoint study-performance or patient-safety concerns.

• Implement preventive and corrective action plans to mitigate risks and enhance compliance.

• 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 in accordance with executed contracts, as applicable.

⛳️ Requirements

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

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

• A minimum of 6 months of experience in clinical research monitoring involving investigational drug or device trials.

• Familiarity with risk-based monitoring, including 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 applicable policies.

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

• Ability to effectively operate in a dynamic environment with competing projects and deadlines.

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

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

• Ability to develop and leverage site relationships through engagement, motivation, and training.

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

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

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

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