"Alerted.org

Job Description

A Regulatory Compliance Coordinator position is currently available within the Tisch Cancer Center. The incumbent will work with investigators and the Cancer Clinical Trials Office (CCTO) infrastructure to manage cancer clinical trials for the division. Duties include, but are not limited to, management of clinical studies through the regulatory portion of the trial submission process, ensuring regulatory integrity of assigned clinical trials from approval to closure, develop new clinical trials and act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. The position will report into the Manager of Regulatory

Individuals should be comfortable with working in a team environment and will be expected to work collaboratively with investigators and administration. Cancer protocols include industry-sponsored, consortium, NCI projects, and investigator-initiated studies.

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.

Qualifications

+ 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:

+ Exposure to clinical research in an academic setting.

+ Excellent written and oral communication skills.

+ Analytical skills for problem solving; attention to detail and accuracy.

+ Ability to manage multiple tasks & priorities.

+ Working knowledge Good Clinical Practice guidelines and Federal research regulations. Demonstrate strong organizational and communication skills.

+ Oncology experience required; some medical knowledge preferred.

Responsibilities

+ Protocol development: Provides regulatory support to clinical trial project teams. Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents, as needed per protocol.

+ Develops and/or revises regulatory policies and procedures.

+ Submits protocol applications for IRB review in a timely manner; tracks new protocols through the committee system to approval, responds to committees’ inquiries for clarification,

+ Gathers data needed to prepare and process applications for IRB review and approval.

+ Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork, for approval of new clinical research trials.

+ Collaborates with the Clinical Trials Manager in developing and ensuring regulatory compliance with respect to clinical trials.

+ Coordinates conference calls with investigators to aid in study development.

+ Participate in Clinical Trial Feasibility, Site Selection Process and the Site Initiation Visit which includes conducting interviews with scientists, doctors and academics and others in a network of industry experts.

+ Obtains IND# for the clinical trials through correspondence with the FDA, and submission of paperwork necessary to obtain an IND#.

+ Collaborates with the Financial Manager on the development of the study budget (as needed); identifies billable versus research non-billable tests for the budget.

+ Updates and maintains records of protocols on clinicaltrials.gov website. Analyzes moderate to complex clinical research data related to i.e. oncology, immunology, microbiology, etc; Assists in interpreting clinical research data used in scientific publication. Must have strong science background.

+ Coordinates the communication of protocol sites, including: protocol approvals, and the distribution of all applications to investigators, and other departments.

+ Upon protocol approval, transitions the protocol to be implemented by investigator(s), program manager(s), clinical research coordinator(s), regulatory coordinator(s),, and research nurse(s).

+ Organizes and conducts start-up meetings for new protocols.

+ Ensures proper regulatory compliance in accordance with sponsoring agency requirements. Maintains study specific regulatory binder(s).

+ Works with auditors and auditory committees to assess trial compliance and related issues.

+ Able to read and understand scientific pre-clinical data being applied to conduct clinical trials. Prompt PIs and Research RNs about protocol requirements for upcoming study visits.

+ Mentors and trains less experienced staff including Clinical Research Coordinators.

+ Performs other related duties as assigned.

About Us

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 Statement

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 $65585.32 - $98827 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.