We are seeking a Senior Quality Control Specialist/ Auditor to support the implementation of M3 Wake Research quality initiatives. In this role, you will conduct audits to ensure our operations comply with Standard Operating Procedures (SOPs), local and federal regulations, ICH-GCP guidelines, and specific protocols as needed. Your responsibilities will include a range of auditing activities, such as internal process audits, pharmacovigilance system audits, and study-specific audits, all aimed at enhancing M3 Wake Research’s quality assurance efforts.Essential Duties and Responsibilities:Including, but not limited to the following:Perform comprehensive audits of clinical research protocols as assigned by the M3 WR Quality Team Management and/or upon Sponsor notification of impending audit.Prepare for scheduled audit by thoroughly reading and understanding assigned protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies.Conduct regulatory document review for the selected protocolConduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc.Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encounteredSummarize and present audit findings to the Principal Investigator (PI), Site PIs, and study staff at the end of on-site auditing activitiesAnalyze audit findings to appropriately assign major or minor violations, rating the audit, and drafting a Final Audit Report for reviewDocument audit findings and outcomes in a formal audit report; maintain data on auditing activities in theInterprets regulations and guidance documents governing FDA, OHRP, ICH/GCP and applies the interpretation to daily work per the audit plan.Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional quality.Participates in selection of protocols to be audited based on risk matrix.Evaluates the potential risk of compliance deficiencies related to audit outcomes.Assists in the management of external audits by regulatory agencies or business partners.Develops organizational metrics of audit finding reports for management as requested.Reviews corrective action plans (CAP)/audit responses for adequacy.
