Senior Research Regulatory Specialist

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.