Research Data Associate

NYU Langone Health • New York, NY

1d • $53,798 - $53,799

About The Position

NYU Grossman School of Medicine is seeking a Research Data Associate to provide direct data and/or clinical research support for clinical trials, studies, and general research under direct supervision. The role works with School of Medicine and Medical Center staff and departments, including Directors, Managers, Clinical Information Systems, Research Nursing, and Regulatory Services.

The associate supports regulatory and trial operations across complex clinical research, including developing and submitting study materials, obtaining committee approvals, maintaining regulatory records, and coordinating with investigators, study teams, sponsors, and contract research organizations. The position also supports trial activation, staff training, monitoring visits, and audit readiness.

Requirements

• Associate's degree plus one year of related experience, or an equivalent combination of education and experience.
• Computer literacy.
• Good interpersonal, writing, and verbal communication skills.
• Ability to communicate effectively with all levels of the organization.

Nice To Haves

• Bachelor's degree, preferably in science, public health, health education, or a related field.
• Prior experience in a health care setting and/or research-level interviews.
• Prior patient education experience.

Responsibilities

• Maintain knowledge of Good Clinical Practice (GCP), clinical research activities, and guidelines related to consent, ethical conduct, and protection of human subjects.
• Help develop protocol-specific standard operating procedures.
• Complete site qualification questionnaires from potential industry sponsors and assess Hassenfeld Children's Center's ability to participate.
• Conduct pre-study visits to ensure the site meets requirements for conducting clinical trials.
• Collaborate with investigators to prioritize the submission and activation of clinical trials.
• Provide regulatory counsel and guidance to study members.
• Contribute to developing and implementing local protocols, including consent forms, study calendars, letters of intent (LOIs), and single-patient INDs, ensuring conformity with sponsor and NYU specifications.
• Develop trial-specific patient informed consent forms for highly complex clinical trials, including phase 0, 1, 1/2, 2, and 3 trials.
• Prepare, submit, and obtain initial approval from required scientific review committees and external organizations, including the Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee, Radiation Committee, FDA, NIH, NCI, and Cooperative Groups.
• Submit regulatory documents on time, track and control regulatory submissions, and disseminate approvals to support activation timelines.
• Submit study amendments promptly, including changes to protocols, consent forms, and other study documents.
• Obtain continuing approvals from applicable committees and organizations.
• Review, submit, and report IND Safety Reports.
• Create and maintain regulatory master files for industry and investigator-initiated Oncology Trials.
• Assist the clinical team in developing trial-specific training tools for study staff.
• Perform day-to-day activities such as obtaining signatures on regulatory documents, filing study documents, processing personnel changes, revising regulatory documents, and maintaining study binders and electronic folders.
• Organize and prepare Site Initiation Visits with sponsors or CROs and the clinical team.
• Meet and correspond with sponsors and/or CROs during Monitoring Visits and ensure study regulatory files are current and audit-ready.

Benefits

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

What This Job Offers

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