Remote Senior Clinical Research Associate | Site Leader

Novartis AG; United States; A distancia; USD 109.000 - 202.000; Jornada completa

Descripción de la vacante

Novartis AG in the United States is seeking a Senior Clinical Research Associate (Sr CRA) for a field-based, remote role covering an assigned geography. The position requires up to 80% travel by plane or car and does not include relocation support.

You will manage site relationships, conduct on-site and remote monitoring for Phase I–IV trials in line with ICH/GCP, SOPs, and local regulations, and collaborate with cross-functional teams to ensure timely trial conduct and high-quality data.

Formación

• Minimum of 3 years’ experience in site monitoring.
• BS/BA degree, Scientific, Healthcare or related field.
• Excellent knowledge of the drug development process specifically clinical trial/research.
• Knowledge of international standards (GCP/ICH, FDA, EMEA).
• Ability to manage multiple priorities and manage time efficiently.
• Excellent Site management capabilities with demonstrated negotiating and problem-solving skills.
• Strong communicator and presentation skills (oral and written).
• Fluent in English.

Responsabilidades

• Primary site manager and first point of contact between site staff and Novartis.
• Frontline liaison supporting collaboration, milestones, and deliverables.
• Monitor according to legislation, ICH/GCP, and Novartis standards.
• Manage assigned sites/networks conducting Phase I–IV protocols according to monitoring plans and Novartis procedures.
• Conduct site initiation visits and deliver ongoing training for site personnel.
• Continuous on-site/remote monitoring; protocol, GCP, regulatory and process compliance; data integrity and patient safety.
• Facilitate preparation and collection of site- and country-level documents.
• Identify risks, resolve issues, and elevate concerns as needed.
• Collaborate with cross-functional teams to drive efficient study execution.
• Deliver timely, high-quality, robust, reliable site data supporting Trial Monitoring goals.
• Partner with SSU CRA for seamless transition of site responsibility.
• Act as a subject matter expert across study activities when required.

Conocimientos

Site monitoring

Fluent English

Communication skills

Educación

BS/BA in Scientific/Healthcare field

Descripción del empleo

Novartis AG in the United States is seeking a Senior Clinical Research Associate (Sr CRA) for a field-based, remote role covering an assigned geography. The position requires up to 80% travel by plane or car and does not include relocation support.

You will manage site relationships, conduct on-site and remote monitoring for Phase I–IV trials in line with ICH/GCP, SOPs, and local regulations, and collaborate with cross-functional teams to ensure timely trial conduct and high-quality data.