Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM * O

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We have an exciting opportunity to join our team as a Clinical Research Coordinator. Reporting to the RBMU Program Manager, the incumbent will be primarily responsible for initiating the biospecimen components of research studies in the most optimal fashion at designated collection locations. Ensure the accurate execution of research protocols in accordance with Standard Operating Procedures, Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor.

Maintain sufficient clinical trial kit supply inventories and manage distribution of clinical specimen kits to necessary locations. Directly interface with the research team and sponsor-contracted 3rd party laboratories in support of the clinical trials. 5% Mentorship.

• Coordinate the lifecycle of biological materials including but not limited to: collection, transport, processing, handling, identification, storage, and shipping of biospecimens.
• Coordinate transport and receipt of collected research biofluid samples on a daily basis.
• Maintain clinical trial biospecimen collection supply inventories for multiple studies at the same time. Monitors General Laboratory supply levels and requests additional resources when needed.
• Interpret study collection plans and generate sample collection source document materials. Understand the principles of all research tests performed in research clinical trials.
• Act as point of contact for designated biospecimen collections. Respond to requests for clinical collection materials in a timely manner, give/receive correct information, encourage required dialogue/follow-through.
• Centrifuge, process, prepare, ship, and/or store biological materials in accordance with sponsor protocols, institutional standard operating procedures, Environmental Health and Safety requirements, and universal Biohazard precautions.
• Perform bench work as needed, perform advanced specimen processing techniques under direct supervision.
• Maintain clean laboratory facilities and shared bench spaces. Work with teammates to share general laboratory responsibilities.
• Record, update, edit, and maintain confidential information relating to research biospecimens onto paperwork and/or web-based forms in a neat, accurate and timely manner and ensure subsequent data collection as required.
• Help to reconcile any biospecimen discrepancies in data with RDAs and RCs. Resolve queries stemming from inappropriately reported and or recorded specimen data or missing specimens.
• Maintain study specimen inventories and Perform Quality Control Analysis on specimen collection records utilizing enterprise databases for all specimens handled and distributed.
• Complete necessary Biological Hazard training provided for the proper handling and collection of biological substances and the packaging and shipment of human biofluid samples.
• Provide updates to study team members regarding changes to workflow or research lab-related specific needs according to protocol modifications.
• Under direct supervision, collaborate with various NYU School of Medicine and Hospital personnel involved in assisting with specific aspects of each study.
• May attend Site-initiation visits and monitoring visits in relation to protocol specimen requirements.
• May participate in the feasibility and complexity assessment process for new protocols.
• Under direct supervision, write relevant standard operating procedures or work instructions.
• Train and mentor new Associate CRCs on general laboratory biosafety, compliance standards, and clinical trial specimen processing techniques.
• Performs all responsibilities in accordance with Standard Operating Procedures, CAP accreditation, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.
• Additional responsibilities as needed including:
  Help in the development of SOPs, policy changes, education sessions, and quality improvement projects.

• To qualify you must have a Bachelor's Degree or equivalent combination of education and experience required.
• Computer literate with good…