Clinical Research Associate II – Immunology

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

📋 Description

• Propel AbbVie’s clinical research pipeline by facilitating clinical trials.

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

• Provide relevant information regarding clinical trials and connect stakeholders with investigative sites.

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

• Perform site evaluations, site training, routine monitoring, and site closure assessments.

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

• Create and tailor site engagement strategies.

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

• Assist in the execution of clinical trials and adherence to protocols.

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

• Acquire knowledge of the therapeutic area, asset, clinical landscape, and patient journey.

• Mentor and train less experienced Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

• Identify and address site risk signals and implement preventive and corrective action plans.

• Identify and assess potential investigators and clinical sites.

• Ensure the quality and punctual submission of site data and safety-event reports.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as necessary.

⛳️ Requirements

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

• A minimum of 1 year of clinically relevant experience.

• 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.

• Knowledge of 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.

• Capability to work efficiently in a fast-paced environment with competing projects and deadlines.

• Proficiency in leveraging technology, tools, and resources.

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

• Ability to build relationships and establish trusted partnerships with sites.

• Critical thinking and sound judgment for addressing issues at clinical sites.

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Availability of remote work options.