Remote Senior Clinical Research Associate – Site Management

Syneos Health, Inc.; Saint Paul (MN); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate to support regionally across the US from Saint Paul, MN. The CRA will monitor trials, ensure regulatory and GCP compliance, and collaborate with site staff to drive data quality and study timelines.

You will travel up to 75% and work across Investigator sites, with responsibilities spanning site qualification, initiation, monitoring, and close-out, while maintaining audit readiness and sponsor communications.

Formación

• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Must demonstrate good computer skills and be able to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to manage required travel of up to 75% on a regular basis.

Responsabilidades

• Performs site qualification, initiation, interim monitoring, and close-out visits, on-site or remote, ensuring regulatory and ICH-GCP compliance.
• Verifies informed consent and protects patient confidentiality.
• Conducts source document review and data entry validation in CRFs.
• Manages IP inventory, labeling, storage and release per protocol.
• Maintains ISF and TMF alignment and appropriate archival of documents.
• Supports recruitment, retention and tracking of observations; enters data into tracking systems.
• Coordinates site staff training and ensures timelines and deliverables are met.
• Prepares for Investigator Meetings and sponsor meetings; supports audit readiness.

Conocimientos

GCP/ICH Guidelines knowledge

Computer skills

Communication & interpersonal skills

Travel up to 75%

Educación

Bachelor's degree or RN in related field

Descripción del empleo

Syneos Health, Inc. is seeking an Experienced Clinical Research Associate to support regionally across the US from Saint Paul, MN. The CRA will monitor trials, ensure regulatory and GCP compliance, and collaborate with site staff to drive data quality and study timelines.

You will travel up to 75% and work across Investigator sites, with responsibilities spanning site qualification, initiation, monitoring, and close-out, while maintaining audit readiness and sponsor communications.