Quality Assurance Coordinator, Audits & Inspections Program – EMEA – Home Based

Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.

Our talented team of 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What a QA Coordinator Does At Worldwide

The Audits and Inspections QA Coordinator is responsible for supporting Sponsor audits and Regulatory Inspections of Worldwide Clinical Trials; inclusive of planning, organizing, reviewing documentation and follow up.

What You Will Do

• Set up of audit and inspection folders to share information/data.
• Compile document requests in advance, during, and post audit and inspections.
• Work closely with Worldwide individuals to support tasks linked to the overall facilitation and management of Sponsor audits and regulatory inspections, including preparation, planning, execution, follow up and associated administrative tasks.
• These may include but are not limited to: Schedule audit interviews and meetings, develop internal agenda based on scope, requesting set up and access for external auditor(s), obtain and QC audit related documents such as training files, study plans, validation documents, presentations, etc., communicate with Worldwide Subject Matter Experts to fulfil document and/or information requests, track and manage audit requests to completion, support the follow up on CAPA commitments.
• Participates in the driving continuous process improvements.
• Provides support for Inspections in relation to Worldwide provided services, as assigned.

What You Will Bring To The Role

• Demonstrate good decision making such as the ability to collect and assess information to determine what is appropriate evidence based on audit request, objective thinking and appropriately weighing different options that may be provided by internal individuals, identifying alternatives to the audit request based on Worldwide processes and creating efficiencies without compromising a successful audit outcome.
• Effective communicator that is concise, clear, and consistent to external and internal customers both verbally and in writing
• Work well under pressure and meet timelines accordingly.
• Ability to handle multiple projects simultaneously in a fast-paced environment.

Your Experience

• Bachelor’s Degree or four-year degree equivalent, with a focus in nursing, biological, physical, health, pharmacy other major related in a scientific or allied health field
• Minimum of 2 years of experience within Clinical Research or a regulated environment.
• Ability to be flexible and work both UK and US hours, as needed
• Working knowledge of the drug development lifecycle and Good Clinical Practice
• Working knowledge of ICH Guidelines, FDA regulations, European Directives and MHRA Statutory Instruments

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at www.worldwide.com/careers! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.