Clinical Research Associate I – Neurology

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Enhance AbbVie's clinical research pipeline by facilitating the execution of clinical trials.

• Act as the main liaison for investigative sites.

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

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

• Conduct site assessments, training, routine monitoring, and site closure activities under supervision.

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

• Tailor site engagement strategies and monitor progress utilizing CRM tools.

• Assist in the development of patient recruitment and retention strategies based on the patient disease journey.

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

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

• Implement preventative and corrective measures to mitigate risks and enhance compliance.

• Identify, assess, and recommend investigators and sites under supervision.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contract obligations.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) preferred, or comparable experience/work history.

• Experience in clinically related roles, ideally in clinical research coordination or data management.

• Familiarity with therapeutic area indications is preferred.

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

• Ability to collaborate effectively across functions.

• Strong planning and organizational capabilities; adept at managing multiple projects and deadlines.

• Proficiency in utilizing technology, tools, and resources.

• Critical thinking skills and sound judgment regarding clinical site matters.

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

• Capability to establish and leverage relationships and trusted partnerships with sites.

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

• Self-driven, punctual, and focused on quality.

• Eligibility to work in New Jersey or New York.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer benefits and support for reasonable accommodations.