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

NYU Langone Health • New York, NY

9h • $70,482 - $76,450

About The Position

NYU Grossman School of Medicine is seeking a Clinical Research Coordinator for its Research Biofluid Management Unit (RBMU). Reporting to the RBMU Program Manager, the coordinator initiates biospecimen components of research studies at designated collection locations and ensures accurate protocol execution in accordance with Standard Operating Procedures, Good Clinical Practices, HIPAA, and obligations to patients or subjects, Principal Investigators, research teams, and sponsors. The role maintains clinical trial kit inventories, distributes specimen kits, and interfaces with research teams and sponsor-contracted laboratories. The stated schedule is Monday through Friday, 11 AM to 7 PM, and the position includes 5% mentorship responsibilities.

The coordinator manages biological materials throughout their lifecycle, including collection, transport, processing, handling, identification, storage, and shipping. The position performs and documents specimen-related work, maintains clean laboratory facilities, supports protocol compliance and quality control, and communicates with study teams and institutional personnel. Under supervision, the coordinator may assist with advanced specimen processing, develop procedures, participate in study feasibility activities, and train new Associate Clinical Research Coordinators.

Requirements

• Bachelor's degree or an equivalent combination of education and experience.
• At least 2 years of clinical research experience or related research laboratory experience.
• Computer literacy and proficiency with Microsoft Word, Excel, Access, PowerPoint, and Outlook; familiarity with internet applications.
• Good interpersonal, writing, verbal, and communication skills, including the ability to communicate effectively with all levels of the organization.
• Ability to work under supervision.
• Ability to identify, analyze, and solve problems.
• Time-management skills and ability to work well under pressure.
• Intermediate competency in medical terminology.
• Advanced competency in Good Clinical Practice guidelines, federal regulations governing human-subjects research, and Institutional Review Board and institutional policies and procedures related to human-subjects research.

Nice To Haves

• Bachelor's degree preferably in science, public health, health education, or a related field.
• Professional certification such as ACRP CCRC or SOCRA CCRP.
• CITI GCP and C-14 certifications; employees without these certifications must obtain them within one year of starting in a CRC role.
• Three years of oncology clinical research experience.
• Prior experience with laboratory information management systems (LIMS).

Responsibilities

• Coordinate the lifecycle of biological materials, including collection, transport, processing, handling, identification, storage, and shipping.
• Coordinate daily transport and receipt of collected research biofluid samples.
• Maintain biospecimen collection supply inventories for multiple studies, monitor general laboratory supply levels, and request additional resources when needed.
• Interpret study collection plans and generate sample collection source documents; understand the principles of research tests performed in clinical trials.
• Serve as a point of contact for designated biospecimen collections and respond promptly to requests for clinical collection materials.
• Centrifuge, process, prepare, ship, and store biological materials according to sponsor protocols, institutional procedures, Environmental Health and Safety requirements, and universal biohazard precautions.
• Perform bench work as needed and, under direct supervision, perform advanced specimen processing techniques.
• Maintain clean laboratory facilities and shared bench spaces and share general laboratory responsibilities with teammates.
• Record, update, edit, and maintain confidential biospecimen information on paperwork and web-based forms accurately and promptly, and ensure subsequent data collection as required.
• Help reconcile biospecimen data discrepancies with Research Data Associates and Research Coordinators; resolve queries related to incorrectly reported or recorded data and missing specimens.
• Maintain study specimen inventories and perform quality control analysis on specimen collection records using enterprise databases.
• Complete required biological hazard training for handling and collecting biological substances and packaging and shipping human biofluid samples.
• Update study team members about workflow changes and research laboratory needs resulting from protocol modifications.
• Under direct supervision, collaborate with NYU School of Medicine and hospital personnel involved in study activities.
• May attend site-initiation and monitoring visits related to protocol specimen requirements.
• May participate in feasibility and complexity assessments for new protocols.
• Under direct supervision, write relevant standard operating procedures or work instructions.
• Train and mentor new Associate Clinical Research Coordinators on laboratory biosafety, compliance standards, and clinical trial specimen processing techniques.
• Perform responsibilities in accordance with Standard Operating Procedures, CAP accreditation, established guidelines and work instructions, and applicable industry and Good Clinical Practices standards.
• Assist with development of SOPs, policy changes, education sessions, and quality improvement projects as needed.

Benefits

• Comprehensive benefits and wellness package.
• Financial security benefits.
• Generous time-off program.
• Employee resource groups for peer support.
• Employee wellness program covering physical, mental, nutritional, sleep, social, financial, and preventive-care well-being.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level