Remote GCP Auditor | Clinical Compliance & QA Expert

FDA Quality and Regulatory Consultants LLC; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

FDAQRC is seeking a qualified Good Clinical Practice Auditor for a full-time remote role. You will conduct audits to ensure compliance with GCP guidelines and other regulations, review protocols and study reports, and prepare audit reports.

Ideal candidates have 3–5 years of audit experience at sponsor, site, CRO, or clinical level, and possess knowledge of applicable regulations and GCP training credentials. Bachelor’s degree in life sciences or related field preferred.

Qualifications

• Excellent communication skills, both written and verbal.
• Understanding of medicine and clinical research principles.
• Knowledge of Good Clinical Practice guidelines and other relevant regulations.
• Experience conducting audits.
• Experience providing training in GCP.
• Ability to conduct research and analyze data.
• Certifications in relevant areas, such as GCP, regulatory affairs, or quality assurance, are beneficial.

Responsibilities

• Conduct audits to ensure compliance with GCP and applicable regulations.
• Review protocols and study reports.
• Conduct on-site or remote audits.
• Produce audit reports.
• Maintain knowledge of relevant regulations.

Skills

Communication

Clinical research knowledge

GCP knowledge

Audit experience

GCP training

Research & data analysis

GCP/regulatory certifications

Education

Bachelor's degree in life sciences or regulatory affairs

Job description

FDAQRC is seeking a qualified Good Clinical Practice Auditor for a full-time remote role. You will conduct audits to ensure compliance with GCP guidelines and other regulations, review protocols and study reports, and prepare audit reports.

Ideal candidates have 3–5 years of audit experience at sponsor, site, CRO, or clinical level, and possess knowledge of applicable regulations and GCP training credentials. Bachelor’s degree in life sciences or related field preferred.