Senior Clinical Research Monitor (Remote) - Tisch Cancer Center

The Senior Clinical Research Monitor is responsible for performing ongoing internal reviews of research projects where human subject research is involved to ensure Investigators are compliant with federal regulations and guidelines governing clinical research, good clinical practices and institutional policies and procedures. The Senior Clinical Research Monitor mentors and advises less senior staff.

Responsibilities

• Performs ongoing internal reviews of regulatory and essential documents, standard operating procedures (SOP), subject case files, protocol compliance, data and safety monitoring, and pharmacy and/ or device documents (investigational product compliance)for IRB approved trials conducted by Tisch Cancer Institute.
• Conducts Exit Conference with Investigator and research team staff to review observations.
• Assist study teams in preparation for regulatory agency inspections and external audits. Participates in the conduct of agency inspections and external audits. Provides support to the Quality Assurance team, Principal Investigator, study team, and other key stakeholders before, during and after inspections and/ or audits.
• Assists in the development of education materials, quality improvement initiatives, root causes analyses, and corrective and preventative action planning.
• Generates audit reports analysis in accordance with the Mount Sinai School of Medicine's standard formats and timelines.
• Performs, where applicable, and at the request of the IRB and/ or Clinical Research Support Unit Leadership, audits of clinical trials.
• Assists with the development of Risk Assessment tools and templates in order to identify and correct compliance issues and/ or implement process improvement.
• Recommends changes in policies and procedures to ensure compliance with regulatory and federal guidelines.
• Trains, advises and mentors less senior staff.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in a Science reputed company field; Masters Degree preferred
• 7+ years of experience as a clinical research coordinator is required to include at least 5 years of progressive auditing/monitoring experience
• ACRP (Association of Clinical Research Professionals) Certification strongly preferred

Company

Strength through reputed company and Inclusion

The reputed company is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. reputed company 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 reputed company 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 reputed company employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and reputed company 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 reputed company and advance professionally. Explore this opportunity and be part of the next chapter in our history.

About the reputed company:

reputed company is one of the largest academic medical systems in the reputed company 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 reputed company people, everywhere, by taking on the most reputed company health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the reputed company of medical leaders and innovators; and supporting local communities by delivering high-quality care to reputed company 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 reputed company 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 reputed company, Westchester, Long reputed company, 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. reputed company 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 reputed company in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. reputed company’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in reputed company and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The reputed company is an equal opportunity employer, complying with reputed company applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national reputed company, 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 reputed company faculty, staff, reputed company, 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 reputed company aspects of our organization.