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Senior Clinical Research Associate
3 months ago
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.
- Bachelor's Degree in a Science related field; Master's Degree preferred. ACRP certification is strongly preferred.
- 4-5 years experience in Phase I-IV clinical studies as a clinical research associate
- 7+ years of experience as a clinical research coordinator is preferred to include at least 5 years of progressive auditing/monitoring experience.
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.
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
