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Position Summary:

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.

Job Responsibilities:

1. Coordinate the lifecycle of biological materials including but not limited to: collection, transport, processing, handling, identification, storage, and shipping of biospecimens.
2. Coordinate transport and receipt of collected research biofluid samples on a daily basis.
3. 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.
4. Interpret study collection plans and generate sample collection source document materials. Understand the principles of all research tests performed in research clinical trials.
5. 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.
6. 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.
7. Perform bench work as needed, perform advanced specimen processing techniques under direct supervision.
8. Maintain clean laboratory facilities and shared bench spaces.  Work with teammates to share general laboratory responsibilities.
9. 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.
10. 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.
11. Maintain study specimen inventories and Perform Quality Control Analysis on specimen collection records utilizing enterprise databases for all specimens handled and distributed.
12. Complete necessary Biological Hazard training provided for the proper handling and collection of biological substances and the packaging and shipment of human biofluid samples.
13. Provide updates to study team members regarding changes to workflow or research lab-related specific needs according to protocol modifications.
14. Under direct supervision, collaborate with various NYU School of Medicine and Hospital personnel involved in assisting with specific aspects of each study.
15. May attend Site-initiation visits and monitoring visits in relation to protocol specimen requirements.
16. May participate in the feasibility and complexity assessment process for new protocols.
17. Under direct supervision, write relevant standard operating procedures or work instructions.
18. Train and mentor new Associate CRCs on general laboratory biosafety, compliance standards, and clinical trial specimen processing techniques.
19. Performs all responsibilities in accordance with Standard Operating Procedures, CAP accreditation, established guidelines and work instructions, and appropriate industry and Good Clinical Practices standards.
20. Additional responsibilities as needed including: Help in the development of SOPs, policy changes, education sessions, and quality improvement projects.

Minimum Qualifications:

To qualify you must have a Bachelor's Degree or equivalent combination of education and experience required.
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, 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 such as Word, Excel, Access, Power Point and Outlook. Familiar with Internet applications.
Intermediate competency in medical terminology, and an advanced competency in Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research.

Preferred Qualifications:

Bachelor's 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.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

View NYU Grossman School of Medicine's Equal Employment Opportunity (EEO) policy. Know Your Rights: Workplace discrimination is illegal.

NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $67,771.14 - $75,955.36 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

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