Clinical Research Associate II

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

📋 Description

• Propel AbbVie's clinical research pipeline forward and facilitate innovative medicines and solutions.

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

• Provide context for clinical trials, connect stakeholders with investigative sites, and enhance AbbVie's positioning.

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

• Perform site evaluations, conduct site training, engage in routine monitoring, and oversee site closure activities while adhering to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, 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.

• Link study protocols and scientific principles to the everyday execution of trials.

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

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to assist in recruitment and protocol adherence.

• Mentor and train less experienced CRAs and aid in their professional development.

• Engage in global and local task forces and initiatives.

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

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

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

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

• Maintain audit and regulatory inspection preparedness at assigned sites.

• Oversee investigator payments in accordance with executed contract obligations, as necessary.

⛳️ Requirements

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

• Prior experience as a CRA is mandatory, with duties in investigation monitoring and similar roles.

• 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 techniques, both onsite and off-site.

• Knowledge of relevant therapeutic area indications is preferred.

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

• Excellent cross-functional collaboration abilities.

• Strong planning and organizational skills; capable of working effectively in a dynamic environment with competing projects and deadlines.

• Proficient in utilizing technology, tools, and resources effectively.

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

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

• Ability to apply functional expertise, critical thinking, and sound judgment to resolve clinical site challenges.

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

• Self-driven and focused on achieving timely, quality outcomes.

• Regular driving and eligibility to operate a company vehicle, in accordance with AbbVie policies and procedures.

🏝️ Benefits

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

• Medical, dental, and vision insurance options.

• 401(k) retirement plan.

• Short-term incentive programs.

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