Quality Specialist

Circuit Clinical is on a mission to transform the way people find, choose, and participate in clinical research.

As a winner of the 2021 Inc. Magazine’s Best Workplaces for 2021, Fast Company’s World Changing Ideas Award for 2021, and 2020 Best Places to Work award by the Buffalo Business First periodical, we work hard to make sure our culture is focused on transparency, accountability, performance, continuous learning, talent, and inclusion. Just as we are obsessed with the patient experience in clinical trials, we are equally obsessed with the employee experience.

What we offer:

We are proud to offer competitive benefits, salary, and an environment focused on helping you grow personally and professionally.

What you’ll do:

As the Quality Specialist, you will be responsible for the ongoing review of all documentation that supports the proper conduct of clinical trials and standard business operating procedures within the company. These tasks aid in ensuring compliance and preparing for auditing activities. This position will work closely with the Clinical Operations and Clinical Quality Management Teams as well as other departments across the organization.

You’ll be responsible to:

• Conducts quality reviews to ensure organizational quality standards and external regulations are met
• Develop Corrective and Preventative Action (CAPA) plans for identified trends or major findings with root cause analyses and effectiveness review plans
• Monitor performance and maintain database of internal and external findings in order to identify and address any quality or compliance issues or trends.
• Review, edit and draft SOPs as needed to support company processes and compliance.
• Assist with preparation and resolution of findings for external audits or inspections.
• Collaborate with the appropriate Teams to manage and resolve internal and external issues identified
• Participate in the development of educational activities and programs as it pertains to quality and compliance.
• Conduct periodic audits remotely or at various clinical sites across the company.

Who you are:

• First and foremost, you have integrity in all that you do. You take a professional approach to your work and don’t compromise your ethical standards.
• You are able to multitask without missing details or deadlines.
• Your attention to detail is among your finest qualities and don’t miss a beat despite the fast-paced environment.
• You are organized and approach your work systematically.
• You are a great communicator - both verbally and written and understand when to escalate issues.
• You are analytical and possess a problem solving attitude.
• You are able to grasp new concepts quickly and to assimilate data from a range of areas.
• You have strong, professional negotiation and arbitration skills.
• You are able to work well in a team environment and can take initiative when needed.
• You value what we value:
  Thoughtful transparency, Expansive Inclusion, Relentless Performance, Fearless Accountability, Talent Obsession, and Continuous Learning.
• Associate’s Degree AND two years in a compliance or quality related role, preferably in a healthcare, research or other science related field, OR an equivalent combination.

Your preferred experience:

• Proficiency with the English language
• Previous Clinical Research Associate/Monitoring experience a plus
• Knowledge of Institutional Review Board, Food Drug Administration and Good Clinical Practice guidelines required
• Knowledge of scientific and clinical research terminology
• Experience recognizing deviations in clinical assessments, normal and abnormal laboratory values, and clinical outcomes
• Demonstrated proficiency with electronic data capture systems, interactive web/voice response systems, and electronic medical record systems
• Demonstrated proficiency with Microsoft Office

Who you’ll report to:

• Reporting to our Quality Assurance Manager, you will be part of our top notch Research Operations Team and work closely with Clinical Operations.

The other fine print:

• Location: This position is a fully remote position. We are hiring in the following states: NY, NJ, PA, MY, WI, and MO.
• Travel: Visits to clinical study site(s), which include hospitals and physician…