Job Type

Full Time




1 Gustave L. Levy Place
New York
New York
United States



A Regulatory Manager is sought for an NIH-funded randomized clinical trial (PI, Dr. Guy Montgomery) investigating the clinical efficacy of a mind-body intervention to reduce pain and improve medication adherence in women with breast cancer who are prescribed aromatase inhibitors. The Regulatory Manager will provide regulatory, administrative, and other research support to the project, and will be part of a team including research assistants, clinical psychologists, and medical oncologists. Successful candidates will have a high degree of professional maturity, empathy, commitment to excellence, attention to detail, independence, flexibility, and creativity.

Key Responsibilities:


  • Ensure regulatory requirements are met in accordance with NIH, GCP (Good Clinical Practice), and HIPAA (Protection of Human Research Subjects) standards, including maintaining all study documents (e.g., regulatory binder)
  • Lead preparation for and conduct monitoring visits by study sponsor organizations
  • Monitor efforts related to human research participant protection and report instances of noncompliance to the appropriate compliance office. Respond to any audit findings and implement approved recommendations
  • Maintain effective and ongoing communication with the project sponsors and the principal investigator
  • Ensure all study activities and personnel comply with current IRB regulatory requirements and procedures; responsible for the timely submission of initial and continued Mount Sinai IRB approval
  • Track project progress through various activities (e.g., organize team meetings, set agenda, take meeting minutes and follow up with team to ensure progress on agenda items)
  • Develop appropriate progress reports for the PI, study funding agency, and the IRB
  • Arrange meetings of study partners, develop meeting agendas, and facilitate meetings
  • Assist the PI in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
  • Screen subjects for eligibility using specific inclusion and exclusion criteria
  • Recruit participants to the trial, independently obtain informed consent for clinical studies and educate participants regarding study requirements
  • Assist in data collection, medical chart abstraction, entry, analysis, and presentation; attend training sessions
  • Maintain adequate inventory of study supplies
  • Perform other research tasks as needed


  • Provide administrative support to the Center for Behavioral Oncology, including ordering supplies, ordering and distributing participant incentives, processing staff reimbursements, and submitting invoices for subcontractors and vendors

Minimum Education:

Bachelor’s degree in social sciences (e.g., psychology, sociology) or related field

Minimum Related Experience:

  • 2-3 years of clinical trials experience including protocol management and IRB compliance
  • Previous experience with participant recruitment
  • CFR familiarity

Minimum Computer Skills:

Advanced MS Office (Word, Excel), Outlook


General Skills:

  • Well-developed interpersonal skills
  • Ability to work well independently as well as with co-workers, peers, supervisors and patients
  • Excellent written and oral communication skills
  • Exceptional attention to detail and accuracy
  • Ability to manage multiple tasks and priorities
  • Experience working as part of a multidisciplinary team
  • Interested individuals must be able to maintain a flexible schedule

Preferred Qualifications:

  • Previous experience conducting monitoring visits with study sponsors
  • Experience with Microsoft Access
  • Passion for psychological/behavioral research


The Mount Sinai Health System is committed to the tenets of diversity and workforce that are strengthened by the inclusion of and respect for our differences. We offer our employees a highly competitive compensation and benefits package, a 403(b) retirement plan, and much more.

The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.

Professional Level


Minimum Education Required

4-year degree

How To Apply

Interested individuals should e-mail a cover letter and CV to:

James Force (