Research Regulatory Specialist

Employment Type

: Full-Time

Industry

:



NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU 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 School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.

Position Summary:


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

The Research Regulatory Services Specialist provides administrative, regulatory, and operational support for OSR. Responsible for the registration, updating, and reporting of results on the ClinicalTrials.gov website in accordance with federal, state, and university policies. Requirements may include management of projects and process execution. Serves as programmatic liaison with NYU departments and institutional offices, as well as external institutions and research sponsors.

Job Responsibilities:

  • Create and maintain clinical trials registration entries on ClinicalTrials.gov for NYU Langone-initiated studies. Identify studies in need of registration (clinical trials) on ClinicalTrials.gov. Review study protocols to prepare the registration records, review the content with faculty researchers, and submit the registration. Contact researchers at regular intervals to obtain updated study information to prepare and submit clinicaltrials.gov registration updates. Upon completion of trials, guide the Principal Investigator in providing the necessary data to prepare and submit study results to ClinicalTrials.gov as required by regulation and policy. Review and resolve Protocol Registration System (PRS) warnings, errors, inquiries, and problem records. Create and maintain individual CT.gov accounts under the master NYU Langone account. Track all CT.gov activities in departmental database. Evaluate and monitor procedures and methods related to ClinicalTrials.gov compliance on an ongoing basis; recommend and implement new or revised procedures as needed.
  • Stay current and advise the RRS Director on ClinicalTrials.gov updates by attending monthly National Clinical Trials Registration Taskforce meetings and monitoring CT.gov listservs. Provide expert interpretation of guidance on clinical trials registration requirements from various entities, including: Food and Drug Administration, International Committee of Medical Journal Editors (ICMJE), Centers for Medicare & Medicaid Services (CMS), and National Institutes of Health (NIH). Develop and conduct education programs and resources related to Clinical Trials for the research community.
  • In conjunction with other RRS staff, identify studies for posting on iConnect, NYUs clinical study registry website. Review content prepared by researchers and/or create new content by reviewing the protocol and consent. Format the content using HTML tags and obtain feedback on the draft from the study team before posting to the iConnect site.
  • Manage the Clinical Trials hotline to match potential research subjects with clinical research studies in which they may be eligible to participate. Manage Research Opt-Out hotline and email mailbox. Record the patient opt-out requests in the institutional database and in Epic.
  • Perform other duties as assigned.

Minimum Qualifications:


To qualify you must have a Bachelors degree, preferably in a health-related or clinical field (such as nursing, biomedical sciences, medical laboratory science).
Two years of relevant experience or an equivalent combination of education and experience.
High proficiency in using various Microsoft Office applications such as World, Excel, PowerPoint and Outlook. Effective oral, written, communication, interpersonal, critical thinking, and time management skills.
Ability to work within a team environment as well as independently.
Ability to develop and lead educational programs, and to train groups and individuals.

Preferred Qualifications:


Graduate degree in a relevant field a plus.
Familiarity with human subjects research, related regulations, study design, and basic statistics.
Prior experience working with ClinicalTrials.gov and clinical research management systems.
Demonstrated ability to work on detailed analyses of complex policies, regulations, statutes and guidelines, problem solve and follow through on assignments with minimal direction.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU 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 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 School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Position Summary:
The Research Regulatory Services Specialist provides administrative, regulatory, and operational support for OSR. Responsible for the registration, updating, and reporting of results on the ClinicalTrials.gov website in accordance with federal, state, and university policies. Requirements may include management of projects and process execution. Serves as programmatic liaison with NYU departments and institutional offices, as well as external institutions and research sponsors.

Minimum Qualifications:
Bachelors degree, preferably in a health-related or clinical field (such as nursing, biomedical sciences, medical laboratory science).
Two years of relevant experience or an equivalent combination of education and experience.
High proficiency in using various Microsoft Office applications such as World, Excel, PowerPoint and Outlook. Effective oral, written, communication, interpersonal, critical thinking, and time management skills.
Ability to work within a team environment as well as independently.
Ability to develop and lead educational programs, and to train groups and individuals.

Preferred Qualifications:
Graduate degree in a relevant field a plus.
Familiarity with human subjects research, related regulations, study design, and basic statistics.
Prior experience working with ClinicalTrials.gov and clinical research management systems.
Demonstrated ability to work on detailed analyses of complex policies, regulations, statutes and guidelines, problem solve and follow through on assignments with minimal direction.


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