Jobs for People with MS: National MS Society

JOB DESCRIPTION

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.

RESPONSIBILITIES

• 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

QUALIFICATIONS

• Bachelor Degree in the Sciences or related discipline.

• The position requires 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

Non-Bargaining Unit, ICG - Medicine MCTO - ISM, Icahn School of Medicine

REQUIRED SKILLS

MS Excel

MS PowerPoint

MS Word

ABOUT US

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.

• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.

• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

Explore more about this opportunity and how you can help us write a new 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 43,000 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 approximately 7,400 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 and top 20 in Cardiology/Heart Surgery, 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. 14 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.

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. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.”

EOE Minorities/Women/Disabled/Veterans

Requisition ID : 3017996