Clinical Trials Manager-Center for Psychedelic Psychotherapy and Trauma Research

We are seeking a Clinical Trials and Regulatory Affairs Manager for an exciting opportunity to help launch and establish the Center for Psychedelic Psychotherapy and Trauma Research (the Center) at the Icahn School of Medicine at Mount Sinai in collaboration with its affiliate the James J. Peters Veterans Affairs Medical Center in the Bronx (Bronx VA). The incumbent will also work on other clinical studies of Post-traumatic Stress Disorder (PTSD)through the Traumatic Stress Studies Division including a study designed to prevent the development of PTSD. The Center will provide novel clinical treatments with MDMA psilocybin and other psychedelics through FDA-approved research protocols. The mission of the Center is to perform rigorous clinical trials on existing and novel psychedelic-assisted psychotherapies in trauma survivors and to apply state-of-the art scientific methods to understand their mechanism of action. The Center seeks to provide education and training to therapists medical residents and trainees to position them to work with these therapies. The incumbent will be an integral member of the research and leadership team and will be responsible for programmatic support of all clinical trials as well as various existing project within Dr. Yehudas laboratory.

Plan and oversee regulatory activities for development of psychedelic assisted psychotherapy and other clinical trials; provide expertise and strategy
Based on deep understanding of clinical trial operations and management of clinical trials you will be responsible for preparation of study protocols case report forms patient consent forms study monitoring procedures internal review board submission documents clinical study reports case study reports as well as study site contracts for FDA regulatory trials investigator-initiated trials and pharma partner trial projects.
Manage the regulatory submission process and interactions with regulatory agencies such as FDA DEA and local IRBs. This includes maintaining continuing approvals from various committees and organizations (In-house: Scientific Committee Institutional Review Board Biosafety Committee)
Ensure compliance with GCP and regulatory guidelines
Standardize all Center operations and establish clear documented protocols
Submission of study amendments in a timely fashion including changes to the protocol consent forms and other study documents
Prepare for and facilitate internal and third-party audits as necessary
Supervise research coordinators on all aspects of regulatory documentation and submission. Important skills:
Attention to detail
Excellent oral and written communication skills
Well organized with project and time management skills.; ability to plan and coordinate many moving pieces to achieve results especially the development of new projects.
Ability to work as a member of a team
Expertise in clinical trials required; experience with medical and/or psychiatric research and academic settings a plus.
Sense of mission Experience:

• Bachelors degree in Nursing Biology and Public Health or related scientific/health field Masters preferred.
• 6 years of experience managing clinical trials including 2 years in a management/leadership role
• Working with a sponsor company (biotech/pharmaceutical company) ideally in hospital setting Working knowledge of FDA and other government regulations required Knowledge of MS Office suites