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 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.

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 internal colleagues and external providers involved in biospecimen collection and handling 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. 

Physical and Mental

• • Ability to sit for long periods of time, stoop, reach, bend throughout the course of the workday.
  • 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.

Other

• • 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.

Minimum Education or Equivalent Experience Required/Preferred:

• Bachelor’s degree in science or related field and one year of related experience.
• Professional experience in clinical research or sample sourcing is preferred.
• Experience in sample processing techniques in a clinical/diagnostic laboratory.
• Experience working in a CLIA certified clinical laboratory is an asset.
• Knowledge of regulations related to general requirements for the transport and importation of biological samples is an asset.
• Basic understanding of the in vitro device development process

Competencies Required or preferred:

• Energetic, highly motivated, effective communicator and adaptable to change.
• Analytical thinking, detail-oriented, customer service oriented, problem solving, results driven.
• Ability to manage competing priorities and meet target dates in a fast-paced environment.
• Ability to read, understand and follow company SOPs, Guidelines and ensures compliance to all aspects of daily activities.
• Ability to maintain regular attendance and punctuality requirements.
• May be required to work additional hours outside of the normal work shift to ensure business commitments are met.
• Computer proficiency with Microsoft Office Suite
• Proficiency in reading, writing, and communicating in English.

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*