Clinical Biospecimen Associate Job Locations US-OH-Cincinnati Company Meridian Bioscience, Inc. Department Research and Development

of Openings

1 About Meridian 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. Job Summary The Clinical Biospecimen Associate (CBA) is a professional responsible for the procurement and management of biospecimens, collected for medical or scientific purposes, to support the product lifecycle across diagnostics sites. The CBA plays a crucial role in ensuring the quality, integrity, and proper documentation of biospecimens throughout the collection, processing, storage, and distribution processes. The CBA is also responsible for providing logistical support to the clinical trial team, ensuring smooth and efficient conduct of clinical trials. Key Duties Tasks/Duties/Responsibilities: Biospecimen acquisition and management Responsible for the external biospecimen acquisition for cross functional teams such as Clinical Affairs, Research & Development, Operation Control & Support, and technical services. Initiate and develop relationships with external collection sites and commercial vendors to procure a large variety of biospecimen types, often with rare biomarkers. Track biospecimens from time of order through delivery, storage and distribution to other functions, to control chain-of-custody and enable specimen reconciliation. Assist in the administrative management of biospecimen acquisition related expenses. (Purchase order requests & processing invoices) Oversee and coordinate all internal specimen collections. Participate in the management of internal collections' advertisement, recruitment, eligibility and enrollment of donors; oversight of contract phlebotomist/nurse duties and tasks; protection of the safety, rights and welfare of donors and management of the confidentiality and secured storage of donor data. Collaborate to the coordination and execution of the specimen acquisition operations and logistics. Maintain biorepository inventory to include archived leftovers and clinical trial sample remnants. Ensure accuracy and completeness of biospecimen data in the inventory. Ethics and Compliance: Communicate with central Institutional Review Boards (IRBs) or directly with collection site/supplier to obtain evidence of IRB approval of protocol and informed consent (IC) or waiver of IC. Stay updated on relevant regulations, guidelines, and best practices governing the handling and storage of biospecimens, including HIPAA, CLIA, and FDA regulations. Contribute to the development and implementation of quality improvement initiatives. Participate in quality assurance activities to ensure compliance with standard operating procedures (SOPs) and Good Clinical Practice (GCPs) guidelines. Ensure that all aspects of the clinical biospecimen storage and management onsite comply with SOPs, relevant regulatory requirement, and ethical standards. Perform quality control checks on collected and processed biospecimens to ensure accuracy, integrity, and compliance with regulatory requirements. Training and Development: Provide training and guidance on best practices and regulatory requirements to inte