Senior Research Regulatory Specialist

NYU Grossman School of Medicine; New York (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

NYU Grossman School of Medicine in New York, NY invites a Senior Research Regulatory Specialist to lead pre-activation regulatory activities for oncology trials and supervise up to 3 FTEs. You will serve as the internal project manager for the disease group and coordinate with sponsor, CRO, IRB, FDA, and NYU departments.

The role requires a Bachelor's degree and 3 years of oncology research experience with strong regulatory knowledge, superb communication, and mentoring skills.

Qualifications

• Bachelor's degree required; 3 years oncology research experience.
• Working knowledge of government codes and regulations.
• Excellent communication, analytical, presentation and time management skills.
• Knowledge of MS Office, databases and terminology used in oncology trials.

Responsibilities

• Initiate contracts & budgets of clinical trials in the internal system for activation.
• Directly communicate with local and national regulatory authorities.
• Complete site qualification questionnaires and assess PCC capability.
• Conduct pre-study visits to ensure site readiness for trials.
• Create regulatory master files for oncology trials.
• Develop trial-specific informed consent forms for complex trials.
• Support development of local protocols, grants, LOIs and INDs.
• Organize site initiation visits with sponsor/CRO and clinical team.
• Assist in developing trial staff training tools.
• Prioritize submissions and activation of trials with investigators.
• Submit regulatory documents timely and track approvals.
• Provide regulatory counsel to study members.
• Mentor junior regulatory staff.
• Maintain knowledge of GCP and human subject protection.
• Assist in developing departmental SOPs.

Skills

Regulatory compliance

Project management

Communication

Analytical skills

Time management

Education

Bachelor's degree

Master's degree in Public Health or Health Administration

Tools

MS Office

Job description

Position Summary:

We have an exciting opportunity to join our team as a Senior Research Regulatory Specialist.The Senior Research Regulatory Specialist will be responsible for programmatic support to initiate clinical trials as well as direct supervision for up to 3 FTEs. Reporting to the Manager of Regulatory Affairs Unit, your specific responsibilities will include all pre-activation responsibilities. You will serve as the internal project manager for the specific oncology disease group(s) for which you are assigned and provide the group timely updates on the status of submissions and regulatory guidance on study development. Additionally you will serve as the liaison between the sponsor, CRO, IRB, FDA and internal departments/ staff.

Job Responsibilities:

• Initiating contracts & budgets of clinical trials in the internal system (CDAs & CTAs) 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 PCC 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 oncology trials.
• Develop trial specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
• 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.
• Assist the clinical team in the development of trial specific training tools for the study staff.
• 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.
• 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 counsel and guidance to study members.
• Mentor junior regulatory staff.
• 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 departmental standard operation procedures.

Minimum Qualifications:

To qualify you must have a Bachelor's degree. 3 years of research related experience in oncology; and a working knowledge of government codes/regulations is required. Excellent working knowledge of regulatory compliance requirements and procedures Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications. Extensive knowledge of oncology clinical trials and oncology terminology required. Exceptional communication, analytical, presentation and time management skills. Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.

Preferred Qualifications:

Master's degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable. Minimum of 4 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required.

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 $70,481.60 - $99,750.00 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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