Senior Quality Control Manager

Summary

Join M3 Wake Research, an M3USA Company, as a Sr. Quality Control Manager in a remote position with up to 40% travel. Conduct audits to ensure operations comply with SOPs, local and federal regulations, ICH-GCP guidelines, and specific protocols.

Requirements

• Bachelor’s Degree in a scientific field, or equivalent experience require
• Certified clinical research professional from an approved accrediting organization (e.g., ACRP, SOCRA) preferred
• Deep knowledge and experience with OHRP and FDA regulations governing clinical research and ICH GCP guidelines
• 10+ years’ experience in clinical research
• Prior work experience in a clinical quality, clinical compliance, or clinical auditing role

Responsibilities

• 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 protocol
• Conduct 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 encountered
• Summarize and present audit findings to the Principal Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities
• Analyze audit findings to appropriately assign major or minor violations, rating the audit, and drafting a Final Audit Report for review
• Document audit findings and outcomes in a formal audit report; maintain data on auditing activities in the
• Interprets 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

Benefits

• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance