Clinical Research Regulatory Specialist

NYU Grossman School of Medicine; New York (NY); In loco; USD 66.000 - 81.000; Tempo pieno

Vantaggi offerti da questo lavoro

Financial security benefits

Generous time-off

Employee resource groups

Wellness program

Descrizione del lavoro

NYU Grossman School of Medicine in New York seeks a Research Regulatory Specialist to support initiation and oversight of clinical trials within the Division of Endocrinology. You will act as internal regulatory liaison for sponsor, CRO, IRB, FDA and NYU teams, coordinating submissions and study development.

Responsibilities include coordinating contracts and budgets, preparing regulatory master files, consent forms, and ensuring compliance with GCP and regulatory standards across multiple

Competenze

• Minimum 2 years of research experience and a Bachelor's degree required.
• Strong knowledge of regulatory compliance requirements and procedures.
• Proficient with MS Office, databases, and data management tools.

Mansioni

• Initiating contracts & budgets of clinical trials in the internal system for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
• Directly communicate with local and national regulatory authorities.
• Complete site qualification questionnaires from potential industry sponsors and analyze division ability to participate.
• Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
• Creation of regulatory master files for industry & investigator-initiated endocrinology trials.
• Develop trial specific patient informed consent forms for clinical trials
• Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient INDs to ensure they conform to the sponsor & NYU specifications.
• Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
• Collaborate with investigators to prioritize the submission and activation of clinical trials.
• Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
• Maintaining updates to regulatory documents and submitting modifications as needed.
• 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).
• Provide regulatory guidance to study members.
• Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.

Conoscenze

Regulatory compliance

MS Office

Data management

Communication

Time management

Formazione

Bachelor's degree

Master's degree in Public Health/Health Administration or relevant science

Strumenti

MS Office

Database software

Descrizione del lavoro

NYU Grossman School of Medicine in New York seeks a Research Regulatory Specialist to support initiation and oversight of clinical trials within the Division of Endocrinology. You will act as internal regulatory liaison for sponsor, CRO, IRB, FDA and NYU teams, coordinating submissions and study development.

Responsibilities include coordinating contracts and budgets, preparing regulatory master files, consent forms, and ensuring compliance with GCP and regulatory standards across multiple