Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the
possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

The Clinical Trial Assistant (CTA) is responsible for coordinating the logistics and supply chain activities associated with clinical trials while adhering to regulatory requirements. This includes planning, distribution of study supplies and instruments to ensure they reach clinical trial sites in a timely and compliant manner.

The CTA is also responsible for providing administrative and logistical support to the Clinical Affairs team, ensuring the smooth and efficient conduct of clinical trials. This role involves collaboration with various stakeholders, including suppliers, regulatory authorities, Clinical Affairs team members and collaborators from other departments.

Tasks/Duties/Responsibilities:

• Prepare and maintain study binders and essential documents.
• Support in administrative tasks, such as maintaining trial related files and records
• Prepare and review shipping documentation, including import/export requirements.
• Prepare and submit import permit requests to regulatory authorities.
• Track supplies and materials to and from study sites

Inventory Management:

• Monitor and maintain clinical inventory stocks to include instruments, consumable supplies, and other clinical trial related materials.
• Purchase of clinical trial supplies.
• Support biospecimens team with biospecimen storage, data entry and biospecimen inventory management, as needed.
• Maintenance of clinical affairs owned instruments which includes cleaning, extracting and deleting data, updating software/firmware version and running checks/controls to confirm adequacy before shipment per standard procedure.
• Implement best practices for instruments and study supplies inventory control.
• Identify and promptly address any challenges, issues or shortages related to the supply chain.

Logistical Support:

• Assist in the planning, coordination and preparation of shipments and receipts of clinical study related materials, supplies, instruments, and samples
• Manage the distribution and tracking of clinical trial supplies (may include biospecimens)
• Develop and maintain supply chain plans, including forecasting, procurement, and distribution strategies

Communication and Collaboration:

• Communicate effectively with all internal and external stakeholders to ensure smooth trial operations, provide updates on supply chain status, and address any supply-related issues or concerns.
• Work closely with Clinical Project Managers and Clinical Research Associates to provide updates on supply chain status and address any instrument and supply-related issues or concerns.
• Participate in quality assurance activities to ensure compliance with standard procedures and Good Clinical Practice (GCP) guidelines.
  Contribute to the development and implementation of quality improvement initiatives.

Training and Development:

• Stay informed about the latest developments in good biorepository practices and clinical trial regulations and procedures.
• Participate in relevant training programs to enhance knowledge and skills related to clinical trial support and biorepository management.

Other duties as assigned by direct supervisor or above.

• Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the workday.
• Ability to lift up to 15 pounds.
• Must be able to concentrate, analyze and solve practical issues throughout the course of the workday.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
• Clinical trials will involve materials that are considered potentially biohazardous. Willing to work with hazardous chemicals and biological agents with proper protective equipment and environmental conditions.
• Must be able to adhere to applicable biosafety practices when on the manufacturing floor or in laboratories.

• Either 2 years of experience in a similar position or a college degree in one or more of the following disciplines: Clinical Affairs, Medical Affairs, R&D, Regulatory Affairs or equivalent functions required.
• Experience in in vitro diagnostics of clinical chemistry and/or infectious diseases an asset
• ACRP/SoCRA certification and/or experience working in a CLIA certified clinical laboratory, an asset.
• General knowledge of clinical laboratory sample collection, processing and testing techniques
• Prior experience handling biological samples preferred.
• Ability to manage competing priorities and meet target dates in a highly dynamic environment
• Highly motivated, and an effective communicator
• Flexibility and adaptability to handle various tasks and collaborate effectively
• Excellent interpersonal and organizational skills, detail-oriented, customer service oriented, critical thinking skills, results driven
• Ability to read, understand and follow company SOPs, Guidelines and ensure compliance with all aspects of daily activities
• Ability to maintain regular attendance and punctuality requirements
• Proficiency in reading, writing, and communicating in English, French is an asset
• Computer proficiency with Microsoft Office Suite
• Proficiency and comfort with micropipette use
• Must be able to work independently. May be required to work additional hours outside of the normal work shift to ensure business commitments are met.
• Possess a valid driver's license and ability to drive company vehicle (van).

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*