Under the supervision of the Principal Investigator, and in collaboration with the Co-Investigators, Clinical Research Coordinators, and Assistant Study Therapists/Session Monitors, the Study Therapist delivers manualized psychedelic drug-assisted therapy sessions and non-drug preparatory and integration talk therapy sessions according to the study protocol, serving as the Lead Session Monitor. The Study Therapist clinically attends to participants during experimental drug administration sessions, which includes monitoring vital signs, completing behavioral assessment instruments, providing verbal support and non-directive clinical presence, and escalating to the on-site medical provider in the event of a psychiatric or medical emergency.
Involves patient care services for a range of mental health conditions ,with primary emphasis on severe substance use disorders, including participants who may present with paranoia or signs and symptoms of psychosis.. The setting is a clinical research study only, not inpatient or outpatient. Care is provided by licensed clinicians working within a multidisciplinary team.
Patients typically require routine assistance, treatment or a specialized and controlled environment. Primary emphasis on protocol-based treatment combining a Schedule I psychedelic, administered under an active IND, with manualized psychotherapy . Technical leader with a high degree of knowledge in psychotherapy for complex behavioral health populations and recognized skill in psychedelic-assisted therapy or a directly transferable modality.
Problem-solving frequently requires clinical judgment in novel situations without established precedent, given the experimental nature of the treatment. Functions with a high degree of autonomy during sessions within the boundaries of the study protocol. May lead in planning and coordinating the clinical work of a multidisciplinary treatment staff; revises and implements new session procedures; conducts training for professional and paraprofessional staff members; and provides psychotherapeutic treatment with emphasis on the most acute and high risk cases.
Given that the study is conducted under an active IND with a Schedule I investigational product, the Study Therapist completes and maintains Good Clinical Practice (GCP) training and adheres to GCP, the IRB-approved protocol, and applicable FDA regulations, including the strict source-documentation standards required for IND studies. Consistent with FDA guidance for psychedelic clinical investigations, the Lead Session Monitor must be an independently licensed clinician (for example, LCSW, LMFT, LPCC, PMHNP, psychiatrist, or licensed psychologist).
Responsibilities % of time Essential Function (Yes/No) Key Responsibilities 5 Conducts patient evaluations. Assesses suitability for inpatient / outpatient care and need for additional services including psychiatric intervention. Completes protocol-specified clinical and safety assessments, including C-SSRS and MADRS-6 at required timepoints, and escalates clinically significant findings to the Study MD or PI. 25 Formulates and implements patient treatment plans.
Conducts individual, family and group therapy / treatment. Provides patient / family education and support. Conducts protocol-specified individual psychotherapy visits, including preparation, treatment, and integration sessions.
Provides therapeutic support during psychedelic dosing visits (approximately 8 hours) using talk therapy and non-pharmacologic interventions such as grounding, meditation, and breathing exercises. 25 Conducts individual and group treatment / activities for patients at the highest level of complexity of care. Supports coordination of care with family, clinicians and agencies. Monitors participants throughout dosing visits, including collection of vital signs and assessment of physical and mental status, and promptly notifies the Study MD of significant abnormalities or concerning symptoms requiring medical evaluation.
Coordinates participant care and safety concerns with the Study MD, PI, and interdisciplinary study team. 20 Assesses impact of intervention / treatment of most advanced cases and evaluates patient progress. Completes patient / participant progress reports. Assesses participant response and progress throughout treatment and identifies, documents, and reports potential adverse events arising during dosing or psychotherapy visits.
Completes required source documentation and progress notes for assigned study visits. 20 Participates in program development and administration. Oversees utilization of resources, quality of care, institutional and regulatory compliance. Participates in weekly interdisciplinary team meetings and clinical supervision to review participant progress and safety concerns.
Conducts study activities and documentation in accordance with the study protocol, treatment manual, and applicable regulatory requirements. 5 Develops proposals and recommendations to guide and support new or innovative programs. May lead intervention teams. Provides clinical feedback and recommendations to refine study treatment procedures, dosing-session workflows, and therapist practices based on implementation experience. 100% Required
Advanced skill providing individual motivational interviewing and psychotherapy In-depth knowledge of applicable laws and ethical standards associated with profession Advanced knowledge of diagnostic and therapeutic approaches in mental health Advanced verbal and written communication. Demonstrated active listening, persuasion and counseling skills Advanced skills in collaborating with heath care providers in a multi-disciplinary setting
Knowledge of data entry software, specialized applications and EHR systems used in clinical research and behavioral health clinics (e.g., REDCap) CITI Good Clinical Practices certification CITI Human Subject Protection certification Education, Licenses and
Graduate-level degree in related area (see Licenses required below) and 5+ years of directly related clinical experience working with people with HIV and mehtamphetamine use disorder Specialized education, certification, or a specific interest in working with psychedelic-assisted therapies in clinical settings Licensed in a behavioral health discipline to practice independently (specifically with any of the following degrees: clinical or counseling psychologist (PhD or PsyD), psychiatrist or other physician (MD or DO), masters-level clinician such a Licensed Clinical Social Worker (LCSW), Licensed Clinical Professional Counselor (LCPC), Licensed Marriage and Family Therapist (LMFT), or Psychiatric Nurse Practitioner (PHNP)
Full time · Day shift