GCP Audit - CRO
RRxCo.™, Phila, PA, United States
We are seeking an experienced
GCP Auditor
to conduct a
CRO Audit
in
Pennsylvania (PA)
on
28th April , on behalf of one of our sponsor biotech clients. The audit will assess the CRO’s compliance with ICH-GCP, FDA regulations, and sponsor oversight expectations. Key Responsibilities:
Conduct a full CRO audit in line with ICH-GCP and FDA regulations Review quality systems, oversight processes, TMF management, vendor oversight, and safety reporting Assess sponsor oversight and CRO performance Identify compliance gaps and provide risk‑based recommendations Prepare and deliver a clear, concise audit report within agreed timelines Communicate findings professionally with sponsor and CRO representatives Requirements:
Strong knowledge of ICH-GCP and FDA regulations Experience assessing CRO quality systems and sponsor oversight processes Able to produce high-quality, risk-based audit reports Available to conduct the audit on 28th April in PA This is a short-term contract opportunity with potential for future collaboration. If you are available and interested, please send your CV and confirm your availability.
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GCP Auditor
to conduct a
CRO Audit
in
Pennsylvania (PA)
on
28th April , on behalf of one of our sponsor biotech clients. The audit will assess the CRO’s compliance with ICH-GCP, FDA regulations, and sponsor oversight expectations. Key Responsibilities:
Conduct a full CRO audit in line with ICH-GCP and FDA regulations Review quality systems, oversight processes, TMF management, vendor oversight, and safety reporting Assess sponsor oversight and CRO performance Identify compliance gaps and provide risk‑based recommendations Prepare and deliver a clear, concise audit report within agreed timelines Communicate findings professionally with sponsor and CRO representatives Requirements:
Strong knowledge of ICH-GCP and FDA regulations Experience assessing CRO quality systems and sponsor oversight processes Able to produce high-quality, risk-based audit reports Available to conduct the audit on 28th April in PA This is a short-term contract opportunity with potential for future collaboration. If you are available and interested, please send your CV and confirm your availability.
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