Research Regulatory Specialist - New York, United States - NYU Langone

Description

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, diversity, 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 diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go to , and interact with us on LinkedIn , Glassdoor , Indeed , __Facebook , Twitter and Instagram .

Position Summary:

We have an exciting opportunity to join our team as a Research Regulatory Specialist.

Serve as liaison between research sponsors, CRO, IRB and internal departments or staff to ensure compliance and management with study requirement and initiatives. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Partners with respective internal and external teams as needed; Interfaces directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable. Provides guidance to Research support staff.

Works autonomously and with limited oversight.

Job Responsibilities

• Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned.
• NYU Office of Clinical Trials/IRB If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Monitors any outward effects or issues regarding patient/subject safety and reports this to the appropriate party. Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
• Reporting and Data Analysis Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes/additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility.
• Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Reminds patient/subjects of visits and compliance in a consistent manner.
• Project Management - Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives.
• Grants - Oversees the preparation of grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division.
• Recruitment - Manages the recruitment process for study/program. Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral,advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
• Decision Making and Problem Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the supervisor.
• Provides guidance, training, leadership to less experienced staff. May have input into staff evaluations.
• Participates in special projects and performs other duties as required.

Minimum Qualifications:

To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with

clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure.

Preferred Qualifications:

Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical

terminology is preferred.

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.

NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.

If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit for more information.

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 $62, $77,168.00 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.

To view the Pay Transparency Notice, please click here

Required Skills

Required Experience