Job Description

A Research Regulatory and Compliance Manager position is currently available within the Tisch Cancer Center. The Research Regulatory and Compliance Manager is responsible for the leadership and support of the Regulatory personnel and participates in all activities for the coordination & preparation of regulatory submissions and design and works with the Clinical Trials manager to implement improvements in communication, monitoring, and enforcement of compliance standards.

The Tisch Cancer Center is a vital component of the Mount Sinai Health System, which is one of the largest health care systems in the nation.   We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.   The primary mission of the CCTO is to assist the Tisch Cancer Center investigators in the development, conduct, and reporting of innovative clinical research in an efficient, compliant, and scientifically sound manner. The CCTO is composed of regulatory, financial, clinical, study management, compliance, and data management personnel that support investigators and provide uniformity and consistency in clinical research. The CCTO provides management and oversight functions for coordinating, facilitating, and reporting cancer clinical trials.

• Responsibility for compiling regulatory submissions to the IRB, either local or central agencies.
• Manage the regulatory department and develop processes so that regulatory submissions are completed in a timely fashion.
• Ensure that all state and federal regulatory requirements are addressed for the clinical research projects. 
  • Develop professional relationships with IRB staff. 
  • Provide regulatory expertise to clinical project teams (importation of clinical trial material, reporting of adverse events).
  • Managing a team that consists of several regulatory coordinators  
  • Careful delegation of tasks whilst maintaining responsibility for final result.
  • Careful planning to achieve accurate and timely results.
  • Develop & maintain regulatory knowledge of current regulations.
  • Manage the final product submissions and negotiate and communicate effectively with regulatory authorities and sponsor representatives to obtain timely project and protocol approvals.
  • Work closely with Clinical Trials Manager and provide the project teams with regulatory input in order to obtain timely regulatory approvals for the project and protocols.
  • Recognize recurring issues and analyze their causes in order to reach a solution.
  • Conduct training sessions for regulatory staff, CRCs, CRAs and Project Managers 
• Acts as liaison, along with the Clinical Trials Manager in working with the Mount Sinai Office of Compliance, to help ensure that the hospitals policies, procedures and operating guidelines conform to laws, regulations and industry practices. 
  • Identify compliance issues that require follow-up or investigation.
  • Work closely with Clinical Trials Manager to enforce policies and procedures related to compliance activities in accordance with established policies and procedures of Mount Sinai Medical Center.
  • Serve as a confidential point of contact for employees to communicate with administrative management, seek clarification on issues or dilemmas, or report irregularities.
  • Conduct periodic Compliance internal reviews or audits to ensure that compliance procedures are followed
  • Maintain documentation of compliance activities, such as complaints received or investigation outcomes.
  • Work closely with the Director of Interventional Cardiovascular Research and the Clinical Trials Manager to identify and discuss emerging compliance issues with management or employees.
  • Work closely with the Director of Interventional Cardiovascular Research and the Clinical Trials Manager to collaborate with human resources departments to ensure the implementation of consistent disciplinary action strategies in cases of compliance standard violations.
  • Along with the training offered by the Mount Sinai Office of Compliance, provide employee training on compliance related topics, policies, or procedures.
  • Work closely with the Clinical Trials Manager, Principal Investigators and coordinators to provide assistance to internal or external auditors in compliance reviews.
  • Communicate concerns regarding violations of compliance or regulatory standards to the Principal Investigator, and Director of Interventional Cardiovascular Research and Clinical Trials as appropriate or required.
  • Verify that all regulatory policies and procedures have been documented, implemented, and communicated.
• Other related duties as assigned by the Director of Interventional Cardiovascular Research and Clinical Trials
  

• Bachelors Degree preferably in a health science or legal/regulatory studies
• 3+ years of direct experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the Medical Device Industry

Preferred:

• 5+ years of Human Subject Clinical Research environment with a strong background and experience working with IRB and regulatory agencies. A broad understanding of research compliance issues preferred
• 2+ years’ experience with Cardiovascular Disease and Cardiovascular Research preferred
  

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

Compensation

The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $65585.32 - $98827 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational 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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