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 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.
- 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
- 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.
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
- 401(k), 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
This position offers a competitive salary of $90,000-$105,000/yr.
*M3 reserves the right to change this job description to meet the business needs of the organization
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