Research Data Associate

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.

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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 providing direct data and/or clinical research in support of clinical trials, studies and general research under direct supervision. Works with School of Medicine and Medical Center staff and departments, including Directors, Managers, Clinical Information Systems, Research Nursing and Regulatory Services.

Job Responsibilities:

• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
• Aid in the development of protocol specific standard operation procedures.
• Complete site qualification questionnaires from potential industry sponsors and analyze Hassenfeld Children's Center ability to participate.
• Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
• Collaborate with investigators to prioritize the submission and activation of clinical trials.
• Provide regulatory counsel and guidance to study members.
• Contribute to the development and implementation of local protocols (including consent forms, study calendars, letter of intents (LOIs)), and single patient IND's to ensure they conform to the sponsor & NYU specifications.
• Develop trial specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
• Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee and Radiation Committee. External: FDA, NIH,NCI, Cooperative Groups).
• Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
• Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents.
• Obtain continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, and Radiation Committee.
• IND Safety Report reviews, submissions, and reporting
• Creation and maintenance of regulatory master files for industry and investigator-initiated Oncology Trials
• Assist the clinical team in the development of trial specific training tools for the study staff.
• Performing day-to-day activities, including but not limited to: obtaining signatures on regulatory documents, filing study documents, processing personnel changes, revising regulatory documents and maintaining study binders/electronic folders
• Organizing and preparing Site Initiation Visits with Sponsor/CRO and Clinical Team.
• Meet and correspond with Sponsor and/or CROs during Monitoring Visits and ensure study regulatory files are up to date and audit ready

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, preferably in science, public health, health education or a related field. Prior experience in a health care settings and/or research level interviews. Prior patient education experience.

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.

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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 - $53,799.20 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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