Clinical Supply Coordinator, Complex Investigational Product

Requisition Number: 7725

Position Title: Clinical Supply Coordinator, Complex Investigational Product

External Description:

Who we are

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 span 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 Clinical Supply Coordinator, Complex Investigational Product does at Worldwide

The Clinical Supply Coordinator plays a key role in strategic oversight, leadership, and coordination of complex investigational product logistics in clinical studies, particularly focusing on cell and gene therapy products. This role is also a key liaison between sponsors, clinical sites, internal teams, and external vendors to ensure seamless logistics management in compliance with regulatory standards and SOPs, while directing end-to-end product handling and ensuring the integrity and efficiency of clinical operations.

This role is the backbone of a strong are the backbone of every strong CRO, helping drive breakthrough scientific research and playing a lead role on every clinical trial. All CROs will promise you growth, opportunity and maybe even a challenge. But we offer more than that. We offer an uncommon experience – one you can’t get anywhere else, with a team unlike anyone else.

At Worldwide we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you daily - committed to advancing science and moving mountains for our customers. 

What you will do

• Serve as the primary point of contact for all stakeholders involved in the logistics of patient cells or investigational products, overseeing collection, processing, transportation, shipment, receipt, and storage.
• Assess protocol requirements and potential logistical challenges, ensuring timely execution of critical steps to meet study objectives and patient safety.
• Develop and maintain a comprehensive documentation required for the process, including but not limited to, a Logistics Manual, collaborating with sponsor teams to ensure adherence to sponsor-directed procedures and regulatory requirements.
• Manage site documentation in conjunction with relevant clinical team, including chain of identity, custody, and shipment conditions, for filing in the Trial Master File (TMF), ensuring compliance with SOPs and local requirements.
• Cultivate strong relationships with third-party vendors, coordinating logistics timelines and mitigating risks proactively.
• Conduct mock logistics runs to assess preparedness and identify areas for improvement in clinical supply.
• Facilitate communication with sites and stakeholders according to the project documentation scheduling manufacturing slots as necessary for assigned studies.
• Establish and maintain Supply Chain-specific databases/trackers for project teams, providing real-time visibility into critical items and milestones.
• Participate in discussions regarding courier selection, storage requirements, labeling, and ancillary supplies.
• Update materials describing the global approach to logistics coordination in the studies with Complex investigational Products for use in proposals and presentations.
• Review requisition forms during transit to minimize errors and ensure compliance.
• Remain vigilant to external factors that may disrupt logistics, adapting plans accordingly to minimize impact on studies.

What you will bring to the role

• Strong planning, organizational, and time management abilities.
• Proficiency in managing multiple projects concurrently.
• Exceptional interpersonal skills and ability to work autonomously.
• Thorough understanding of clinical research principles and processes.
• Capacity to react swiftly to issues, assess their impact, and implement effective contingency plans.
• Familiarity with FDA, EU Directive regulations, ICH Guidelines, and local regulatory requirements.
• Proficiency in Microsoft Office, particularly Excel.

Your experience

• Bachelor's degree in medical, biological, physical, health, pharmacy, or related science field preferred, and minimum 2 years of experience in clinical research, preferably in a managerial capacity OR
• Equivalent education/training and minimum 3 years of clinical research experience. OR
• Relevant education/training and minimum 5 years of clinical research experience.
• 1-2 years of specific knowledge in cell or gene therapy supply chain.

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.

 

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Employment Type: Regular

Community / Marketing Title: Clinical Supply Coordinator, Complex Investigational Product

Company Profile:

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.

Location_formattedLocationLong: North Carolina, US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.