Senior Clinical Research Associate - Remote Sponsor-Focused

Syneos Health, Inc.; Virginia (MN); Hybrid; USD 70,000 - 110,000; Full time

Job summary

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate - Sponsor Dedicated to support monitoring activities remotely in the US. The role involves site qualification, initiation, interim monitoring, and close-out visits with emphasis on regulatory compliance and data integrity.

You will verify informed consent, manage ISF/TMF reconciliation, and assist with site staff training and issue resolution, ensuring alignment with ICH-GCP and SOPs across trials.

Qualifications

• Experience in clinical monitoring and site management.
• Familiarity with ICH-GCP guidelines and SOPs.
• Ability to work remotely with on-site visits as needed.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance. Uses judgment to evaluate site performance and escalate issues to the project team; maintains knowledge of guidelines and regulations.
• Verifies informed consent processes and protects subject confidentiality; assesses safety and data integrity at investigator sites.
• Per the CMP/SMP: Assesses site processes; conducts Source Document Review of site source documents and medical records. Verifies CRF data accuracy and completeness; drives issue resolution within timelines.
• May perform IP inventory, reconciliation and reviews storage and security; ensures IP labeling, import/export per protocol and regulatory requirements.
• Routinely reviews ISF for accuracy, timeliness and completeness; reconciles ISF with TMF and ensures archiving per guidelines.
• Documents activities via letters, logs, trip reports, and other required documents; supports recruitment, retention and tracking of observations.
• For assigned activities, understands scope, budgets and timelines; manages site-level communications to meet goals.
• Acts as liaison with study site personnel and ensures training/compliance of site team members.
• Prepares for and attends Investigator Meetings and sponsor interactions.

Skills

Site qualification

Site initiation

Interim monitoring

Data integrity

ICH-GCP

Source Document Review

ISF/TMF reconciliation

Job description

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate - Sponsor Dedicated to support monitoring activities remotely in the US. The role involves site qualification, initiation, interim monitoring, and close-out visits with emphasis on regulatory compliance and data integrity.

You will verify informed consent, manage ISF/TMF reconciliation, and assist with site staff training and issue resolution, ensuring alignment with ICH-GCP and SOPs across trials.