Contract gcp auditor – investigator site audit
dates: 6th–7th april
location: mexico
engagement: short-term contract
we are seeking an experienced gcp auditor to conduct a two-day investigator site audit in mexico on 6th–7th april, on behalf of one of our sponsor biotech clients.
the audit will assess compliance with ich-gcp, applicable local regulations, and sponsor requirements.
key responsibilities:
* conduct a full investigator site audit in line with ich-gcp and local regulatory requirements
* review essential documents, isf, informed consent processes, imp management, safety reporting, and data integrity
* interview site personnel
* identify compliance gaps and assess overall site performance
* prepare and deliver a clear, risk-based audit report within agreed timelines
* communicate findings professionally with sponsor and site representatives
requirements:
* proven experience conducting gcp investigator site audits (sponsor-side experience preferred)
* strong knowledge of ich-gcp and mexican clinical trial regulations
* fluent spanish and english preferred
* able to produce concise, high-quality audit reports
* available to conduct the audit on 6th–7th april
this is a short-term contract opportunity with potential for future collaboration.
if you are available and interested, please share your cv and confirm your availability.