Quality Assurance Manager, Clinical Research

Education, Training, Compensation and More

In a highly regulated industry such as clinical research trials, the role of quality assurance is paramount to collecting and reporting accurate study data while staying in compliance with company practices, protocol requirements, and federal regulations.

The quality assurance manager of a clinical research site is the primary person in the company concerned with maintaining efficiency by eliminating waste.

This role is responsible for identifying problems before they happen; with every study, there are challenges and potential risks and QA needs to be able to help identify issues ahead of time to make sure staff is prepared.

According to Payscale.com, the salary range for quality assurance manager is wide, from $42,381-$112,054. The website also reports that this job is weighted toward the experienced worker, with more than half of the quality assurance (QA) workers in the United States reporting more than 10 years of experience.

Typical Work Week

Most QA workers in clinical research work eight hours a day, 40 hours a week, but the job requires flexibility and this may require additional hours. Tasks vary from day-to-day depending on scheduled audits, challenges, etc.

Overall, QA is responsible for:

  • Writing policies.
  • Providing updates on regulatory trends in the industry.
  • Establishing procedures and monitoring for feedback and possible improvements.
  • Monitoring staff for compliance with company policies, industry regulations and sponsor requirements.
  • Writing Corrective and Preventive Action (CAPA) plans.
  • When QA observes a person out of compliance, their job is to guide them back into compliance -- giving them suggestions regarding how to become more compliant. Sometimes that means going over company policies, retraining, clarifying and/or fine-tuning our processes. Other times that means thinking outside of the box to discover a new solution that hasn't been thought about for a study.

    QA spends most of its time reviewing study records and company processes for clinical visits. 

    Education and Training

    You can get certified as a QA specialist, but it’s not necessary. There are also training programs offered by colleges, universities and certificate programs. Sometimes the best training is on the job.

    To be successful, a quality assurance manager must become well-versed in good clinical practices and FDA regulations and have a team of other knowledgeable people as a resource. It’s also imperative to develop people skills which will help you gain trust and respect when communicating with coworkers. In some regard we – quality assurance -- are critiquing other people’s work to help them improve professionally, so understanding how to establish professional relationships is necessary for the job.
    It’s also important to be able to keep an open mind because there’s always more than one solution to a problem. Sometimes people may feel as though there is only one way to be in compliance with policies and regulations. If we don’t have an open mind, there’s a good chance that we can miss out on opportunities to improve and grow.  At the same time, a quality assurance manager must know when to stand firm to enforce a particular policy.

    Types of Clinical Research Companies Employing QA Personnel

    If a clinical research facility has a QA department, that’s a sign of a mature site. Generally, research sites don’t start with a QA department but eventually realize the benefit of tasking a dedicated department to improve processes and supply oversight of training and compliance. Having a QA department also shows that the company is dedicated to growing professionally by fine-tuning processes and improving the quality of research studies.

    QA departments are great for marketing purposes because sponsors understand the value in a mature site.

     

    Skill Set

    It’s important to be detail oriented, knowledgeable about regulation, standard operating procedures (SOPs) and site policies. You must also have good follow through, good computer skills, previous experience, excellent communication skills (oral and written), enjoy working with other people and like problem-solving while taking on new challenges. Also, ​it’s essential to continue personal and professional growth.

    Potential Career Track

    Typically, you become a QA auditor/specialist once you start your career track at a research site. From there, you can go into a managing role where you manage other auditors. Once you have a grasp on Good Clinical Practices and FDA regulations coupled with experience in conducting and managing audits it really opens the door for opportunity and growth. Depending on the size of your company, you may have QA Directors (also called Global QA) that oversee other QA managers across multiple research sites. You can even choose a completely different path by offering QA consulting services to research sites and sponsors, or by joining a sponsor’s QA specialty team. This only touches the surface of the opportunity for QA professionals.

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