Remote Clinical Research QA Specialist — GCP/FDA Focus

Saratoga Medical Center; United States; A distancia; USD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Benefits package

Descripción de la vacante

Saratoga Medical Center is hiring a Remote, Clinical Research QA Specialist in the United States. The role focuses on ensuring GCP compliance and leading quality assurance activities for NIH- or FDA-regulated studies, including monitoring SOP development and CAPA effectiveness.

The ideal candidate has 5+ years of quality assurance or clinical research experience with at least 3 years in GCP roles, a life science degree, and QA certification preferred.

Formación

• Bachelor's degree in life science or related field.
• QA certification (e.g., CQA, RQAP-GCP) preferred.
• Minimum of 5 years of quality assurance or clinical research experience.
• At least 3 years in GCP quality functions for NIH- or FDA-regulated studies.
• Strong analytical, documentation and communication skills.
• Experience with ICH E6, 21 CFR Parts 11, 50, 54, 56, 312 and 812 where applicable.
• Current human subjects protections and GCP training (e.g., CITI).
• Experience collaborating with multidisciplinary teams including Government investigators and regulatory staff.

Responsabilidades

• Develop and maintain monitoring SOPs and quality management documents.
• Quality review of monitoring reports, essential documents and regulatory files.
• Track and verify CAPA and effectiveness of corrective actions.
• Conduct or support internal audits and inspection readiness activities.
• Deliver GCP and protocol training for clinical research staff.
• Collaborate with multidisciplinary teams including regulatory staff and program officials.

Conocimientos

Quality assurance

GCP knowledge

Regulatory compliance

Documentation

Audit readiness

Training delivery

Educación

Bachelor's degree in life science or related field

QA certification (e.g., CQA, RQAP-GCP) preferred

Descripción del empleo

Saratoga Medical Center is hiring a Remote, Clinical Research QA Specialist in the United States. The role focuses on ensuring GCP compliance and leading quality assurance activities for NIH- or FDA-regulated studies, including monitoring SOP development and CAPA effectiveness.

The ideal candidate has 5+ years of quality assurance or clinical research experience with at least 3 years in GCP roles, a life science degree, and QA certification preferred.