• New York, NY
• Research
• 3029992
• 08/12/2025
  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.

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.

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.

Employer Description

• 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