Resch. Regulatory & Compliance Manager-Full Time Days - Tisch 015 - Mount Sinai Hospital

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Job Summary:

A Research Regulatory and Compliance Manager position is currently available within the Tisch Cancer Institute. Reporting to the Associate Director of Regulatory Affairs, 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 Institute 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 Institute 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.

Roles & Responsibilities:

Responsibility for compiling regulatory submissions to the IRB, either local or central agencies.

In collaboration with the Associate Director, 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.

I .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 CCTO Senior Leadership to identify and discuss emerging compliance issues with management or employees.

Work closely with the CCTO Associate Director of Regulatory Affairs 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 CCTO Senior Leadership appropriate or required.

Verify that all regulatory policies and procedures have been documented, implemented, and communicated.

Other related duties as assigned by the CCTO Associate Director of Regulatory Affairs

Requirements:

Education:

Bachelor Degree in the Sciences or related discipline.

Experience:

The position requires 5+ years of Human Subject Clinical Research environment, with at least 3 years of experience as a Regulatory Coordinator and a strong background and experience working with IRB and regulatory agencies. A broad understanding of research compliance issues preferred.

2+ years’ experience with Oncology and Oncology Research preferred

Strength Through DiversityThe Mount Sinai Health System believes that diversity and inclusion is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize healthcare delivery together. We work hard to recruit and retain the best people, and to create a welcoming, nurturing work environment where you have the opportunity and support to develop professionally. We share the belief that all employees, regardless of job title or expertise, have an impact on quality patient care. Explore more about this opportunity and how you can help us write a new chapter in our story! Who We AreOver 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospitals, including Mount Sinai Beth Israel, Mount Sinai Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. EOE Minorities/Women/Disabled/Veterans