Good Clinical Practice Auditor

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 a specialized quality consulting firm that provides regulatory compliance and quality assurance solutions to Pharmaceutical, Medical Device, and Biotech companies. Our customized, value-added solutions help optimize business efficiencies while minimizing regulatory risk. With a global team of quality assurance and regulatory affairs experts, we collaborate with our clients to ensure that the right expert is matched to their situation.

Role Description

As a consulting firm, we hire practiced professionals for our roles. This is a full-time remote role for a Good Clinical Practice Auditor. The Good Clinical Practice Auditor will be responsible for conducting audits to ensure that they comply with Good Clinical Practice (GCP) guidelines and other applicable regulations. Day-to-day tasks include reviewing protocols and study reports, conducting on-site or remote audits, and producing audit reports. The Good Clinical Practice Auditor will also be responsible for maintaining current knowledge of relevant regulations.

Candidates must have at least three (five years preferred) of audit experience at the sponsor, clinical, site or CRO level. Broad knowledge of applying relevant regulations to the task is required.

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
• Bachelor's degree in a related field, such as life sciences, healthcare, or regulatory affairs
• Certifications in relevant areas, such as GCP, regulatory affairs, or quality assurance, are beneficial