Senior Quality Control Specialist, Auditor

Summary

Join M3 Wake Research as a Senior Quality Control Specialist/Auditor and contribute to the implementation of quality initiatives. This remote position, with up to 40% travel, involves conducting audits to ensure compliance with SOPs, regulations, and guidelines. You will perform various audits, analyze findings, and prepare reports. The role requires a Bachelor's degree in a scientific field or equivalent experience, along with 5-10 years of clinical research experience and relevant certifications. M3 Wake Research offers competitive wages and a comprehensive benefits package.

Requirements

• Bachelor’s Degree in a scientific field, or equivalent experience
• 5-10 years’ experience in clinical research
• Prior work experience in a clinical quality, clinical compliance, or clinical auditing role
• Ability to travel up to 40%, often at short notice
• Ability to effectively communicate verbally and through written communication
• Ability to project a professional demeanor in representing the department to the broader research community
• Ability to work independently with minimal supervision
• Must be detail oriented and well organized
• Ability to conduct all routine audit activities to expected timelines completely and independently
• Advanced knowledge of relevant Federal regulations and guidelines on clinical research involving human subjects, and a demonstrated ability to apply the regulations to informing their daily work

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

Preferred Qualifications

• Certified clinical research professional from an approved accrediting organization (e.g., ACRP, SOCRA)
• Deep knowledge and experience with OHRP and FDA regulations governing clinical research and ICH GCP guidelines

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
• Competitive salary of $90,000-$105,000/yr