Clinical Research Coordinator, Research Biofluid Management Unit; Monday-Friday, 11AM - 7PM Oncology clinical research experience preferred

NYU Langone Health • New York, NY

5h • $70,482 - $76,450 • Onsite

About The Position

NYU Grossman School of Medicine is seeking a Clinical Research Coordinator for the Research Biofluid Management Unit. This role is primarily responsible for initiating the biospecimen components of research studies, ensuring accurate execution of research protocols, and managing clinical trial kit supply inventories. The incumbent will interface with research teams and third-party laboratories to support clinical trials and will have mentorship responsibilities. The position requires adherence to Standard Operating Procedures, Good Clinical Practices, and HIPAA regulations.

Requirements

• Bachelor's Degree or equivalent combination of education and experience.
• Computer literate with good interpersonal, writing and verbal communication skills.
• Minimum 2 years of clinical research experience or related research laboratory experience.
• Effective oral, written, communication, and interpersonal skills.
• Must be able to work under the direction of supervision.
• Ability to identify, analyze and solve problems.
• Time management skills and ability to work well under pressure.
• Proficiency in using various Microsoft Office applications (Word, Excel, Access, PowerPoint, Outlook) and Internet applications.
• Intermediate competency in medical terminology.
• Advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulations governing human subjects research, and Institutional Review Board and institutional policies and procedures.

Nice To Haves

• Bachelors degree, preferably in science, public health, health education or a related field.
• Professional certification (ACRP CCRC or SOCRA CCRP).
• CITI GCP and C-14 certifications preferred. Individuals without this certification will be required to obtain this certification within one year of starting in a CRC role.
• 3 years of experience in oncology clinical research preferred.
• Prior experience with laboratory information management systems (LIMS) a plus.

Responsibilities

• Coordinate the lifecycle of biological materials including 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 simultaneously and monitor general laboratory supply levels.
• Interpret study collection plans and generate sample collection source document materials.
• Act as a point of contact for designated biospecimen collections and respond to requests for clinical collection materials.
• 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 and advanced specimen processing techniques under direct supervision.
• Maintain clean laboratory facilities and shared bench spaces, collaborating with teammates on general laboratory responsibilities.
• Record, update, edit, and maintain confidential information relating to research biospecimens accurately and timely.
• Help reconcile biospecimen discrepancies in data and resolve queries related to specimen data.
• Maintain study specimen inventories and perform Quality Control Analysis on specimen collection records.
• Complete necessary Biological Hazard training for proper handling, collection, packaging, and shipment of biological substances.
• Provide updates to study team members regarding workflow changes or research lab-specific needs.
• Collaborate with various NYU School of Medicine and Hospital personnel.
• 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.
• Perform all responsibilities in accordance with Standard Operating Procedures, CAP accreditation, established guidelines, and Good Clinical Practices standards.
• Assist in the development of SOPs, policy changes, education sessions, and quality improvement projects.

Benefits

• Financial security benefits
• Generous time-off program
• Employee resource groups for peer support
• Holistic employee wellness program (physical, mental, nutritional, sleep, social, financial, and preventive care)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree