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Job Description

This individual will report directly to the Medicine Clinical Trials Office (MCTO) Research Manager to assist with management of the electronic systems most important to MCTO operations. The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects.

This role includes maintaining the electronic Trial Master File (eTMF) and ensuring compliance with regulatory requirements. The coordinator will work closely with cross-functional teams to ensure that regulatory documentation is accurate, complete, and submitted in a timely manner. The Regulatory Coordinator is responsible for ensuring regulatory compliance across U.S. and international research sites. This role supports the coordination, submission, and maintenance of regulatory documentation in accordance with institutional, federal, and international guidelines. The coordinator will work closely with site teams, sponsors, and regulatory authorities to facilitate timely approvals and ongoing compliance. Additional duties include operational assistance with other essential systems, as well as a variety of special projects; once an understanding of the general duties listed below has been acquired, this individual will coordinate efforts to achieve the performance improvement and systems integration goals of the MCTO.

Qualifications

+ Masters degree in Natural Sciences OR Bachelors degree in Natural Sciences plus 5 years of progressive research experience with some experience in research administration preferred.

+ 4 years of research experience (5 years if no Masters degree) in data management and study coordination in healthcare or basic research.

Responsibilities

Regulatory Oversight & Documentation

+ Coordinate regulatory activities for multi-site clinical trials, including domestic and international locations.

+ Prepare, review, and submit regulatory documents (e.g., IRB/IEC submissions, informed consent forms, site-specificregulatory packets).

+ Collect, organize, and assemble regulatory submissions, including FDA 1572 Forms, financial disclosure forms, andprotocol signature pages.

+ Ensure all required regulatory documents are submitted to sponsors to activate protocols.

+ Distribute IRB documentation to sponsors, research, and clinical staff.

+ Maintain accurate records of all regulatory submissions and correspondence.

+ Prepare, update, and audit study-specific regulatory files, IRB files, and location profile systems in accordance withFDA guidelines.

+ Participate in internal and external audits and inspections as needed.

Systems & Data Management

+ Maintain electronic database systems and spreadsheets to track and document departmental activities.

+ Manage the electronic Trial Master File (eTMF) to ensure it is complete, current, and compliant with regulatorystandards.

+ Organize, scan, upload, and properly index documents within the eTMF system.

+ Conduct regular audits of the eTMF to identify and resolve discrepancies or missing documents.

+ Investigate and implement system integrations/interfaces to improve workflow and data accuracy.

Project Coordination & Reporting

+ Assist in the planning, coordination, and execution of regulatory projects.

+ Track and manage regulatory timelines to ensure timely submissions and approvals.

+ Collaborate with research, regulatory, and finance teams to meet project goals and deadlines.

+ Provide regular updates on project status, issues, and progress to senior management.

+ Provide ad hoc reporting to MCTO leadership as needed.

Training & Team Support

+ Train and support team members on the use of regulatory systems, including the eTMF.

+ Assist MCTO in developing systems learning tools for staff.Communication & Collaboration

+ Serve as a liaison between internal teams and external stakeholders to resolve regulatory issues and facilitateproject progression.

+ Communicate effectively in verbal and written formats with coordinators, staff, management, pharmaceuticalcompanies, IRBs, and other stakeholders.

+ Demonstrate strong teamwork, attention to detail, organizational and planning skills.

+ Prioritize tasks effectively in a multi-task environment.

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 $58661 - $74250 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.