Mount Sinai Health System
Clinical Research Manager-Psychiatry / Clinical Trials Unit
Mount Sinai Health System, New York, New York, us, 10261
Job Description
The Clinical Trials Manager for Psychiatry works closely with the Vice Chair for Clinical Research to support the coordination and execution of investigator-initiated and industry-sponsored clinical trials within the Department of Psychiatry at Icahn School of Medicine at Mount Sinai. The Clinical Trials Manager will work to ensure the operational success and regulatory compliance of a growing portfolio of research studies focused on mental health, including mood disorders, psychosis, anxiety, PTSD, and neurodevelopmental conditions. The manager will provide leadership to a multidisciplinary team of coordinators and research staff, ensuring compliance with institutional policies, ethical standards, and regulatory requirements.
Qualifications
• Bachelor’s degree in psychology, neuroscience, public health, nursing, or related field required; Master’s degree (e.g., MPH, MS, MSW, RN, or related) preferred.
• Minimum 5 years of clinical research experience, with at least 2 years in a trials management role, preferably in psychiatry or behavioral health.
• Thorough understanding of ethical and operational considerations in mental health clinical research, including work with vulnerable populations and cognitively impaired individuals.
• Experience with IRB and regulatory submissions in an academic setting.
• Familiarity with psychiatric rating scales (e.g., HAM-D, MADRS, PANSS, CAPS) and structured clinical interviews is preferred.
• Proficiency in electronic data capture systems (e.g., REDCap, Medidata, or equivalent) and clinical trial management systems (CTMS).
• Certification through ACRP, SOCRA, or equivalent preferred.
• Strong leadership, organizational, and interpersonal communication skills.
• Demonstrated commitment to advancing evidence-based care and improving outcomes for individuals with mental illness.
Responsibilities
• Support the day-to-day operations of psychiatric clinical trials, including recruitment, informed consent, data collection, and protocol adherence.
• Serve as a primary point of contact for investigators, sponsors, IRB, and institutional leadership on psychiatry research studies.
• Oversee development of study protocols, case report forms (CRFs), source documents, and standard operating procedures (SOPs).
• Supervise, mentor, and evaluate clinical research coordinators and assistants supporting psychiatric trials.
• Monitor and report on study metrics, enrollment targets, and regulatory timelines; proactively identify and address barriers to recruitment and retention in psychiatric populations.
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, HIPAA, and IRB requirements specific to mental health research.
• Supervise and support the preparation and submission of IRB applications, amendments, continuing reviews, and adverse event reports.
• Participate in the negotiation and management of study budgets and contracts.
• Coordinate and facilitate site initiation visits, monitoring visits, and sponsor audits with a focus on mental health research standards and best practices.
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 $71713 - $125159.12 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.
The Clinical Trials Manager for Psychiatry works closely with the Vice Chair for Clinical Research to support the coordination and execution of investigator-initiated and industry-sponsored clinical trials within the Department of Psychiatry at Icahn School of Medicine at Mount Sinai. The Clinical Trials Manager will work to ensure the operational success and regulatory compliance of a growing portfolio of research studies focused on mental health, including mood disorders, psychosis, anxiety, PTSD, and neurodevelopmental conditions. The manager will provide leadership to a multidisciplinary team of coordinators and research staff, ensuring compliance with institutional policies, ethical standards, and regulatory requirements.
Qualifications
• Bachelor’s degree in psychology, neuroscience, public health, nursing, or related field required; Master’s degree (e.g., MPH, MS, MSW, RN, or related) preferred.
• Minimum 5 years of clinical research experience, with at least 2 years in a trials management role, preferably in psychiatry or behavioral health.
• Thorough understanding of ethical and operational considerations in mental health clinical research, including work with vulnerable populations and cognitively impaired individuals.
• Experience with IRB and regulatory submissions in an academic setting.
• Familiarity with psychiatric rating scales (e.g., HAM-D, MADRS, PANSS, CAPS) and structured clinical interviews is preferred.
• Proficiency in electronic data capture systems (e.g., REDCap, Medidata, or equivalent) and clinical trial management systems (CTMS).
• Certification through ACRP, SOCRA, or equivalent preferred.
• Strong leadership, organizational, and interpersonal communication skills.
• Demonstrated commitment to advancing evidence-based care and improving outcomes for individuals with mental illness.
Responsibilities
• Support the day-to-day operations of psychiatric clinical trials, including recruitment, informed consent, data collection, and protocol adherence.
• Serve as a primary point of contact for investigators, sponsors, IRB, and institutional leadership on psychiatry research studies.
• Oversee development of study protocols, case report forms (CRFs), source documents, and standard operating procedures (SOPs).
• Supervise, mentor, and evaluate clinical research coordinators and assistants supporting psychiatric trials.
• Monitor and report on study metrics, enrollment targets, and regulatory timelines; proactively identify and address barriers to recruitment and retention in psychiatric populations.
• Ensure compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, HIPAA, and IRB requirements specific to mental health research.
• Supervise and support the preparation and submission of IRB applications, amendments, continuing reviews, and adverse event reports.
• Participate in the negotiation and management of study budgets and contracts.
• Coordinate and facilitate site initiation visits, monitoring visits, and sponsor audits with a focus on mental health research standards and best practices.
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 $71713 - $125159.12 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.