Clinical Research Associate II

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

📋 Description

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

• Act as the main contact for investigative sites.

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

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

• Conduct evaluations, training, routine monitoring, and closure activities for sites.

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

• Formulate and tailor site engagement strategies for assigned studies.

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

• Assist in the execution of clinical trials, patient recruitment, retention, and protocol adherence.

• Guide and mentor less experienced CRAs, contributing to their professional development.

• Engage in global and local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

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

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

• Maintain readiness for audits and regulatory inspections.

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

⛳️ Requirements

• A 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, both onsite and offsite.

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

• Knowledge of therapeutic area indications is preferred.

• Excellent cross-functional collaboration abilities.

• Strong planning and organizational skills.

• Capability to perform effectively in a dynamic environment with competing projects and timelines.

• Advanced skills in leveraging technology, tools, and resources.

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

• Ability to build and maintain site relationships and trusted partnerships.

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

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

• Relevant tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) is preferred.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Option for remote work.

• Equal opportunity employer protections and support for reasonable accommodations.