Clinical Monitoring & Site Management Specialist (Remote)

Syneos Health/ inVentiv Health Commercial LLC; Morrisville (NC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Syneos Health is seeking Clinical Monitoring professionals to perform site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance. The role involves assessing subject safety, data integrity, and coordinating with site staff across trial milestones.

You will handle source document reviews, IP inventory, ISF maintenance, and data capture activities while supporting recruitment and audit readiness in a dynamic, global environment.

Qualifikationen

• Bachelor's degree or RN in a related field.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel up to 75% on a regular basis.
• Must embrace new technologies and have good computer skills.

Aufgaben

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP compliance and protocol adherence.
• Verifies informed consent processes and protects subject confidentiality while assessing safety and data integrity factors.
• Reviews CMP/SMP, source documents, CRFs and data entry; drives query resolution to closure; uses tracking tools.
• Manages IP inventory and ensures proper labeling, import and release in compliance with regulations.
• Maintains ISF accuracy and archiving requirements; supports recruitment and tracking activities.
• Documents activities and coordinates with project teams; supports audit readiness and readiness activities.
• Manages site-level activities, budgets and timelines; communicates with Lead CRA and site staff.
• Acts as liaison with site personnel and trains project team members on requirements.
• Prepares for Investigator Meetings and sponsor meetings; participates in audits and training sessions.
• Supports Real World Late Phase activities with site lifecycle support and data collection.

Kenntnisse

Communication skills

Interpersonal skills

Travel readiness

Regulatory knowledge

Computer literacy

Ausbildung

Bachelor's degree or RN

Tools

Tracking systems

Jobbeschreibung

Syneos Health is seeking Clinical Monitoring professionals to perform site qualification, initiation, monitoring, and close-out visits to ensure regulatory and protocol compliance. The role involves assessing subject safety, data integrity, and coordinating with site staff across trial milestones.

You will handle source document reviews, IP inventory, ISF maintenance, and data capture activities while supporting recruitment and audit readiness in a dynamic, global environment.