What are the responsibilities and job description for the Senior Regulatory Compliance Coordinator- Immunology and Immunotherapy position at Mount Sinai Health Systems?
Description
The Senior Regulatory Compliance Coordinator acts as a mentor to junior staff providing oversight and training to multiple study teams who develop and submit documentation and information for Institutional Review Board (IRB) review and who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies. The Senior Regulatory Compliance Coordinator is a resource for Investigators and Research Teams.
This individual works in a team environment and is expected to work collaboratively with investigators and administration. Protocols include industry-sponsored, consortium, NCI projects, and investigator-initiated studies, cancer protocols or those relevant to the department study projects.
Responsibilities
- Provides regulatory support to clinical trial project teams.
- Assists a multi-disciplinary group of Principal Investigators and researchers with development of investigator-initiated clinical trial protocols. This individual demonstrates an understanding of complex scientific terminology and regulatory requirements.
- Prepares protocol submissions for IRB review in a timely manner and tracks new protocols through the internal study start-up committee to approval and activation, including response to committee inquiries for additional data or clarification.
- Prepares international regulatory submissions, product dossiers and Technical Files/Design Dossiers. Ensures QA of submissions.
- Conducts reviews of labels, literature and Web site for accuracy, consistency and regulatory compliance.
- Develops and/or revises regulatory policies and procedures.
- Prepares annual reports for PMA devices and IND drugs.
- Works with auditors and auditory committees to assess trial compliance and related matters.
- Acts as liaison among research team and sponsor for important clinical trials notices, updates and monitoring visits.
- Performs other duties as assigned.
Qualifications
- Bachelors Degree (Masters preferred) ideally in science or health care policy.
- 5 years preferred of direct experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the Medical Device Industry.
Employer Description
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
Compensation
The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $72473 - $108709 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
Salary : $72,473 - $108,709
