Remote GCP QA Specialist for NIH/FDA Trials

Saratoga Ascend; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Saratoga Medical is seeking a Remote Clinical Research QA Specialist to oversee quality assurance in NIH/FDA-regulated studies. You will develop monitoring SOPs, review regulatory files, and lead CAPA processes while ensuring GCP compliance.

Ideal candidates have 5+ years in clinical research QA, strong documentation skills, and the ability to work in a multidisciplinary team with regulators and investigators. Remote position available in the United States.

Qualifications

• Develop and maintain monitoring SOPs and quality management documents.

Responsibilities

• Develop and maintain monitoring SOPs and quality management documents.

Skills

SOP development

Quality management

CAPA tracking

Internal audits

GCP training

Regulatory documentation

Education

Bachelor's degree in life sciences

Job description

Saratoga Medical is seeking a Remote Clinical Research QA Specialist to oversee quality assurance in NIH/FDA-regulated studies. You will develop monitoring SOPs, review regulatory files, and lead CAPA processes while ensuring GCP compliance.

Ideal candidates have 5+ years in clinical research QA, strong documentation skills, and the ability to work in a multidisciplinary team with regulators and investigators. Remote position available in the United States.