Quality Assurance Specialist

Company Description

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.

Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.

Due to our continued growth, we are hiring a Quality Assurance Specialist at Wake Research, an M3 company. This is a remote position with up to 40% travel.

Job Description

The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams. This role involves collaborating with clinical research staff to address findings, provide recommendations for improvement, and ensure compliance within their area of expertise. The Quality Assurance Specialist will oversee audits and inspections, and work cross-functionally to support continuous quality enhancement across the organization.

Essential Duties And Responsibilities

Including, but not limited to the following:

• Travel to M3 Wake Research sites to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards.
• Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management. Track and follow up on the resolution of review findings.
• Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans to include development, root case analysis, implementation, and evaluation of CAPA plans.
• Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management.
• Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate.
• Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes.
• Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team. Assist with the development or enhancement of training materials.
• Conducts on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires.
• Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum.
• Remain informed about developments in relevant clinical trial requirements, FDA, ICH, GCP, and guidelines within the US and other regions, as appropriate for M3 Wake Research.
• Identify and escalate significant compliance issues.
• Share quality topics and lessons learned to the organization.
• Assist individual sites in development of internal guidance documents to supplement corporate SOPs.
• Assist with quality incident and compliance investigations.
  
  

Qualifications

• Bachelor’s degree or equivalent experience
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes.
• 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role.
• Direct experience in the conduct and reporting of internal and external audits preferred.
• Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred.
• Clinical Research or Quality Certification preferred.
• Excellent interpersonal, verbal, and written communication skills.
• Client focused approach.
• Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills.
• Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization.
• Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams.
• Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment.
  
  

Additional Information

About M3USA

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
• M3 reserves the right to change this job description to meet the business needs of the organization