Research Data Associate

NYU Langone Hospitals; New York (NY); On-site; USD 48,000 - 59,000; Full time

Job summary

NYU Langone Health is seeking a Research Data Associate to coordinate basic level cancer clinical research studies at the Laura and Isaac Perlmutter Cancer Center. You will perform enrollment and data entry, interfacing with investigators and study teams under supervision.

The role involves data coordination, regulatory tasks, and collaboration with radiology, pathology, and research support staff to ensure timely, accurate study documentation and compliance with GCP guidelines.

Qualifications

• Associate's degree plus one year related experience or equivalent combination.
• Bachelor's degree preferred.
• Computer literate with good interpersonal, writing and verbal communication skills.

Responsibilities

• Data entry for cancer clinical studies and enrollment within 1 week or less from last visit.
• Log visits into CRMS to ensure timely billing for research procedures.
• Request pathology reports and tissue acquisition per protocol.
• Coordinate imaging submissions with the Department of Radiology.
• Schedule monitoring visits and coordinate with monitors and staff; manage charts and access.
• Perform vial assignments and assist with eligibility review and subject registration.
• Coordinate SAE submissions to DSMC, sponsor, and IRB.
• Develop understanding of GCP and related regulatory policies.
• Collect patient information and abstract data for publications; maintain data quality and accuracy.
• Attend research meetings and report progress to sponsors.

Skills

Interpersonal communication

Writing skills

Verbal communication

Computer literacy

Education

Associate's degree

Bachelor's degree

Tools

CRMS (Clinical Research Management System)

EMR (Electronic Medical Records)

Job description

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, X and Instagram.

Position Summary:

We have an exciting opportunity to join our team as a Research Data Associate. In this role, the successful candidate is responsible for the coordination of basic level cancer clinical research studies conducted at the Laura and Isaac Perlmutter Cancer Center. Performs enrollment and data entry. Interfaces directly with Principal Investigators, clinical study team members, regulatory specialists, quality assurance specialists, financial coordinators, study monitors, and service rendering departments as needed in support of the cancer clinical trials. Works under general supervision.

Job Responsibilities:

• Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
• Human Subjects Research:

a. Responsible for study data entry and query resolution on all assigned simple studies, ensuring data is entered within 1 week or less from the last study visit.

b. Logging study visits into the Clinical Research Management System (CRMS) as they occur to ensure study sponsors are billed for research procedures in a timely and efficient manner.

c. Requesting pathology reports and tissue acquisition required per the study protocol.

d. Coordinate the submission of imaging with the Department of Radiology.

e. Schedules monitoring visits as needed. Coordinates the visit with the study monitor, the CTO Administrative Assistant and Vornado Realty Trust. Requests charts and access to the Electronic Medical Record for study monitors and records all visits in the Data Coordination Unit (DCU) SharePoint. Communicates the change of a monitor, or additional monitors on site to the Business Operations Unit (BOU) for billing purposes.

f. Perform vial assignments and communicates with the study team and investigational pharmacy in a timely and efficient manner. Assists with eligibility review and subject registration with study sponsors, and within the CRMS system.

g. Coordinates the submission of Serious Adverse Events (SAEs) and other reportable events to the Data and Safety Monitoring Committee when applicable, the study sponsor, and the Institutional Review Board (IRB).

• Regulatory: Develops a working understanding of 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.
• Research Activities - Collects patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.); abstraction of data for publications, or data collection from outside physicians offices. Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc.). Updates the database or the case report forms. Assists in reviewing medical history and screening procedures to confirm patient eligibility on protocol. Reports all adverse events and serious adverse events to applicable agencies. Attends research and committee meetings including DMG Research Meetings and Data and Safety Monitoring Committee Meetings.
• Clinical Competency: Develops an understanding of medical terminology in the oncology field. Navigates and understands how to extract information from the Electronic Medical Record independently. Assist CCU staff in maintaining a follow up calendar ensuring all survival follow up assessments are completed per the protocol.
• Reporting and Analysis Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies. Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Conduct primary analysis to data collected. Formulates, prepares database and generates preliminary measurement reports for review by the PI.
• Participates in special projects and performs other duties as required.

Minimum Qualifications:

To qualify you must have an Associate's degree plus one year related experience or equivalent combination of education and experience. Computer literate with good interpersonal, writing and verbal communication skills.

Preferred Qualifications:

Bachelor's degree

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 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 $53,797.97 - $53,797.97 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.