Company 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