Clinical Research Coordinator II- Neurology

The Nash Family Center for Advanced Circuit Therapeutics (C-ACT) at The Icahn School of Medicine at Mount Sinai is seeking a Clinical Research Coordinator II to support and help coordinate research activities across Center projects utilizing deep brain stimulation (DBS) for neuropsychiatric disorders. Current projects include clinical assessment and study coordination for patients receiving DBS for Treatment Resistant Depression. This is an excellent opportunity to participate in cutting-edge research as a member of a multidisciplinary research team of technical and clinical experts.

The Clinical Research Coordinator II will report to Dr. Mayberg and will interact with research patients and with a diverse team of clinicians (from the Departments of Psychiatry Neurology and Neurosurgery) and scientists who focus on the use of neuroimaging neuroengineering computational neuroscience AI metrics and bioinformatics in the context of invasive neuromodulation both within and across the Center and Institution.

About C-ACT

Located next to Mount Sinai West Hospital the Center for Advanced Circuit Therapeutics (C-ACT) is a transdisciplinary research unit collaborating closely with the Center for Neuromodulation. C-ACT facilitates research utilizing imaging invasive and noninvasive electrophysiology performance and behavioral metrics computational modeling and clinical and research bioinformatics involving patients undergoing surgical neuromodulation for treatment-refractory neurological and psychiatric conditions. This core facility supports the development and implementation of novel neuromodulatory strategies to expedite the delivery of advanced individualized care for patients with complex neuropsychiatric disorders.

Patient-Facing Clinical Responsibilities

• Schedule and coordinate research visits for study participants with clinical staff and research personnel.
• Administer and coordinate routine standardized clinical and behavioral assessments to study participants including psychiatric rating scales (e.g. Hamilton Depression Rating Scale (HDRS) Montgomery-Åsberg Depression Rating Scale (MADRS) and other structured interview instruments.
• Obtain informed consent under the supervision of the Principal Investigator and for all human subject studies.
• Mentor and assist research assistants and graduate/medical students in patient interaction and assessment administration.

Regulatory & Compliance

• Prepare submit and manage FDA IRB DSMB and documentation.
• Draft all new protocol submissions amendments continuing reviews renewals and study closures. Coordinate with the Principal Investigator and institutional offices for physician-sponsored Investigational Device Exemption (IDE) applications and amendments.
• Maintain and organize regulatory binders and trial master files to ensure compliance with institutional FDA and sponsor requirements.
• Assist in managing research contracts and ensuring compliance with grant requirements.

Administrative & Research Support

• Coordinate clinical and grant team meetings and calendars related to ongoing projects.
• Assist with writing new research protocols grant applications and progress reports.
• Manage and maintain study-specific REDCap databases ensuring accurate and complete data entry through record reviews and source document verification in compliance with institutional standards for data integrity quality control and storage.
• Contribute to social media posts participant recruitment materials and other Center communications.

• Bachelors degree in sciences or related field.
• 2 years of clinical research

Preferred Skills

• Masters degree in life sciences neuroscience psychology public health or a related field; or Bachelors degree with equivalent clinical research experience.
• Minimum 2 years of clinical research with clinical trials experience.
• Experience with IRB submissions regulatory documentation and clinical trial management.
• Demonstrated ability to interact sensitively and effectively with patients with neurological and/or psychiatric disorders.
• Strong organizational and interpersonal skills; ability to manage multiple tasks in a fast-paced environment with pristine attention to detail.
• Proficiency in Microsoft Office Suite and REDCap or comparable clinical database platforms.
• Demonstrated ability to work effectively communicate clearly and accomplish goals independently and as part of a team.
• Minimum 2-year commitment to the position.
• Experience administering standardized clinical rating scales (e.g. HDRS MADRSYMRS or similar behavioral instruments).
• Experience with FDA regulatory submissions including IDE applications and amendments.
• Familiarity with neuromodulation therapies (DBS TMS ECT) or neuropsychiatric clinical research.
• Experience with program or project management software (Notion etc).

• Previous supervisory or mentorship experience.