Clinical Research Assistant II Regulatory - Medicine Clinical Trials Office

Description The Regulatory Assistant II plays a vital role in supporting clinical research compliance by managing and maintaining electronic regulatory binders. This position ensures that all regulatory documentation is accurate, current, and audit-ready, while collaborating closely with regulatory affairs teams to uphold institutional and federal standards. Maintaining regulatory compliance in clinical trials is essential for safeguarding patient safety, upholding ethical standards, ensuring data integrity, and facilitating the development and approval of new medical treatments and technologies. This position offers an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful candidate will have the chance to work closely with regulatory affairs professionals and gain valuable experience in the pharmaceutical or healthcare Responsibilities Electronic Binder Management: Assist with all aspects of clinical research regulatory compliance, including document preparation, submission and management for clinical trials. Organize and maintain electronic regulatory binders in accordance with established procedures. Ensure proper version control and document naming conventions are followed. Implement and maintain an efficient filing structure for easy navigation and retrieval of documents. Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies. Document Collection and Review: Collaborate with regulatory affairs team to collect required documents for inclusion in electronic binders. Review documents for completeness, accuracy, and compliance with regulatory standards. Identify and rectify any errors or inconsistencies promptly. Coordinate with stakeholders to address any discrepancies or missing information. Assist team to ensure all site documents, including SOPs and administrative files, are maintained in audit-ready condition. Assist to complete required forms specific to each protocol. Assists with the maintenance of regulatory data in the clinical trial management system (OnCore). Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies. Ensure all regulatory documents are readily accessible and organized for inspection purposes. Other Responsibilities: Participate in required teleconferences, on-site meetings as required. Performs all other related duties as assigned. Prepare for study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. Maintain working knowledge of current regulations, regulatory guidance and or local policies. Qualifications Associates Degree in related field or HS Diploma with equivalent related experience Bachelor's degree preferred 1 year of research experience; preferably in a multi-site trial setting Creative problem solving skills; ability to navigate through ambiguous situations Strong organizational, communication and interpersonal skills Ability to manage competing priorities and deadlines in a fast paced environment Proficiency with MS 365 office suite Employer Description 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 The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $16.5 - $27.3608 Hourly. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Associates Degree in related field or HS Diploma with equivalent related experience Bachelor's degree preferred 1 year of research experience; preferably in a multi-site trial setting Creative problem solving skills; ability to navigate through ambiguous situations Strong organizational, communication and interpersonal skills Ability to manage competing priorities and deadlines in a fast paced environment Proficiency with MS 365 office suite

Electronic Binder Management: Assist with all aspects of clinical research regulatory compliance, including document preparation, submission and management for clinical trials. Organize and maintain electronic regulatory binders in accordance with established procedures. Ensure proper version control and document naming conventions are followed. Implement and maintain an efficient filing structure for easy navigation and retrieval of documents. Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies. Document Collection and Review: Collaborate with regulatory affairs team to collect required documents for inclusion in electronic binders. Review documents for completeness, accuracy, and compliance with regulatory standards. Identify and rectify any errors or inconsistencies promptly. Coordinate with stakeholders to address any discrepancies or missing information. Assist team to ensure all site documents, including SOPs and administrative files, are maintained in audit-ready condition. Assist to complete required forms specific to each protocol. Assists with the maintenance of regulatory data in the clinical trial management system (OnCore). Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies. Ensure all regulatory documents are readily accessible and organized for inspection purposes. Other Responsibilities: Participate in required teleconferences, on-site meetings as required. Performs all other related duties as assigned. Prepare for study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors. Maintain working knowledge of current regulations, regulatory guidance and or local policies.