Regional Clinical Research Associate | Remote & Travel Ready

Syneos Health, Inc.; Yuma (AZ); Remoto; USD 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Syneos Health is seeking an Experienced Clinical Research Associate to be regionally aligned across the US. The role involves site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely, with emphasis on regulatory compliance and data integrity.

You will verify informed consent, protect confidentiality, and assess subject safety. Travel up to 75% is required, and you will collaborate with sponsor teams, manage ISF/TMF, and contribute to audit readiness.

Competenze

• Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
• Strong computer skills and ability to embrace new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% on a regular basis.

Mansioni

• Performs site qualification, initiation, interim monitoring, site management activities and close-out visits (onsite or remotely) ensuring regulatory, ICH-GCP and/or GPP and protocol compliance.
• Verifies informed consent and protects confidentiality; assesses factors affecting subject safety and data integrity.
• Assesses site processes, conducts Source Document Review, ensures CRF data accuracy, and drives timely query resolution.
• Manages IP inventory, reconciliation, and ensures IP dispensing complies with protocol; handles labeling/import/release as needed.
• Reviews Investigator Site File (ISF) and reconciles with Trial Master File (TMF); ensures archiving per guidelines.
• Documents activities, supports recruitment/retention, and enters data into tracking systems for ongoing observations and action items.
• Manages scope, budgets, and timelines; communicates with site team; adapts to changing priorities to meet goals.
• Prepares for Investigator Meetings and sponsor meetings; participates in training; supports audit readiness and compliance.

Conoscenze

GCP/ICH knowledge

Excellent communication

Strong interpersonal skills

Good computer skills

Travel up to 75%

Formazione

Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

Descrizione del lavoro

Syneos Health is seeking an Experienced Clinical Research Associate to be regionally aligned across the US. The role involves site qualification, initiation, interim monitoring, and close-out visits, performed on-site or remotely, with emphasis on regulatory compliance and data integrity.

You will verify informed consent, protect confidentiality, and assess subject safety. Travel up to 75% is required, and you will collaborate with sponsor teams, manage ISF/TMF, and contribute to audit readiness.