Regulatory Compliance Coordinator Tisch Cancer Center

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