Senior Clinical Research Associate - Remote/Field

Syneos Health, Inc.; Atlanta (GA); Vor Ort; USD 70.000 - 110.000; Vollzeit

Zusammenfassung

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate who will be regionally aligned across the United States. The role focuses on site qualification, initiation, monitoring, and close-out visits ensuring compliance with ICH-GCP and local regulations.

You will protect subject safety, review data integrity, and manage site actions remotely or on-site. Expect responsibilities including ISF/TMF management, IP inventory, and collaboration with sponsor teams.

Qualifikationen

• Bachelor's degree or RN in a related field and/or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Excellent communication, presentation and interpersonal skills.

Aufgaben

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits, on-site or remotely, ensuring regulatory, ICH-GCP and GPP and protocol compliance.
• Verifies informed consent processes and protects subject confidentiality; assesses factors affecting subject safety and data integrity.
• Conducts Source Document Review, data verification in CRFs, and drives query resolution to closure; supports IP inventory, labeling, and storage per protocol.
• Maintains ISF accuracy, reconciles with TMF, and ensures archiving of essential documents per guidelines.
• Documents activities, supports recruitment and retention strategies, and uses tracking systems to monitor observations and action items.
• Understands project scope, budgets, and timelines; manages site-level activities and communications; adapts to changing priorities.
• Acts as liaison with site personnel and trains site team members to ensure compliance with requirements.
• Prepares for Investigator Meetings and sponsor meetings; participates in global meetings and attends training sessions as required.
• Provides guidance at site and project level towards audit readiness and supports follow-up actions.

Kenntnisse

Excellent communication skills

Good computer skills

Presentation skills

Ausbildung

Bachelor's degree or RN in a related field

Jobbeschreibung

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate who will be regionally aligned across the United States. The role focuses on site qualification, initiation, monitoring, and close-out visits ensuring compliance with ICH-GCP and local regulations.

You will protect subject safety, review data integrity, and manage site actions remotely or on-site. Expect responsibilities including ISF/TMF management, IP inventory, and collaboration with sponsor teams.