Senior GCP Process Auditor (Fully Remote)

• Support the Quality Management System including SOPs, training, and CAPA processes.
• Host client/sponsor audits and support regulatory inspections.
• Coordinate and conduct vendor, internal, investigator site, and trial master file audits.

Qualifications:

• Extensive working knowledge of GCP Process Audits.
• Bachelor's degree in science, healthcare, or related field.
• Availability to travel up to 25% domestically and/or internationally.

Preferred Experience:

• CRO experience and QA certification (e.g., CQA, SQA) preferred.
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO).