Quality Control Specialist (Clinical Operations)

Company Description
M3 is the global leader in digital solutions in healthcare. We work with a range of sectors including healthcare, life sciences, pharmaceuticals, biotechnology and charities; services provided to these sectors include market research, medical education programs, promotional programs, clinical development, job recruitment and clinic appointment services. M3 has grown by more than 20% year-on-year for the past 15 years, achieving over 1 billion dollars in revenue annually.
Founded in 2000, with start-up investment capital from Sony, M3’s mission is to make use of the internet to increase, as much as possible, the number of people who can live longer and healthier lives, and to reduce, as much as possible, the amount of unnecessary medical costs. Key achievements of M3 Inc. include:
Named in Fortune’s 2020 ‘Future 50’ list, ahead of Facebook and Amazon
Ranked in Forbes’ 2020 Global 2000 list of the world’s largest public companies
M3 is the only company incorporated after the year 2000 to be included in the Nikkei 225 Index
Listed in Forbes’ ‘Asia’s 200 Best Over a Billion’ in 2019
In 2020 M3 founded the ‘M3: Stop COVID-19 Fund’ and pledged one billion yen to support COVID-19 related initiatives
M3’s legacy lies in the power of trusted physician platforms. Around the world, M3 organizations leverage these highly engaged digital communities to deliver medical education, job placement, and market research, to improve global patient outcomes.
Due to our continued growth, we are hiring for a Quality Control Specialist at Wake Research, an M3 company. This is a remote position with up to 40% travel.
About the Business Division:
M3 Wake Research, Inc. is one of the largest independent clinical research site services companies in North America. M3 Wake Research is an integrated network of premier investigational sites working closely with and meeting the needs of the global biopharmaceutical, biotechnology, medical device, pharmaceutical industry, and clinical research organizations. M3 Wake Research has its proprietary patient database of potential clinical trial participants—men and women, children and adults, across all ethnicities—for all kinds of adaptive and other types of trial designs. Conducting studies since 1984, we have a combined subject database of more than 2 million.
M3 Wake Research has 26 owned and managed research sites across 9 states in the US and continues to grow. As of today, our board-certified physicians have completed more than 7,000 successful clinical trials. Clinical trials at our site are always completed on time and with accuracy; we consistently exceed sponsor expectations for integrity, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Our approach is uncompromising – each study conducted at our site is carefully planned and executed according to regulations with superior quality.

Mission of the Role:
The Quality Control (QC) Specialist will conduct quality control reviews in support of clinical research teams. The QC Specialist is expected to work with clinical staff to resolve findings and offer suggestions for improvement. They will serve as a resource for clinical staff regarding issues of compliance within their area of expertise. They will also relay communication issues to site management and/ or the M3 Wake Research leadership team.
Essential Duties and Responsibilities:
Travel to M3 Wake Research sites to conduct internal quality control 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 Control 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 Control management.
Review monitoring letters for assigned sites to identify trends and proactively support the teams to work towards an effective resolution.
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. Provide support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement.
Assist with the development or enhancement of training materials.
Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum.
Remain informed about developments in relevant regulations and guidelines.
Identify and escalate significant compliance issues to the QMS team and Quality Control management, including the assessment of serious breaches.
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
Requirements:
Able to travel up to 40%, at times on short notice.
Bachelor’s degree or equivalent experience
Minimum of 3-5 years in clinical research
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.
Excellent interpersonal, verbal, and written communication skills
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.
Preferred Qualifications
Advanced degree in life science related field
Prior work experience in a clinical quality, clinical compliance, or clinical auditing role
Clinical Research or Quality Certification preferred
Additional Information
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

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