Clinical Research Rater - ECN Operating LLC

Role Overview

Facilitators provide psychological support and safety monitoring for participants in preparatory, dosing, and integration sessions throughout the psychedelic-assisted therapy trial for Major Depressive Disorder using CYB003.

Facilitator Responsibilities

• Conduct Psychological Support Sessions:
  • Three preparatory sessions before each dosing (each lasting 90 minutes).
  • Two dosing sessions (on Day 1 and Day 22).
  • Three integration sessions after each dose (each lasting 90 minutes).
  • All sessions are audio and video recorded per protocol requirements.
  • Sessions may occur in-person or via telemedicine, but at least one preparatory session must be in-person.
• Build and Maintain Rapport:
  • The same facilitators who conducted preparatory sessions should be present for dosing and integration sessions to ensure continuity and trust.
  • If a substitute facilitator is needed, they must have met the participant beforehand.
• Safety and Monitoring:
  • Observe participants during dosing for psychological safety and monitor for adverse events or distress.
  • Report facilitator-observed events and adverse outcomes, escalate to medical team as required.
  • Ensure discharge only occurs after 8 hours and after the investigator has assessed stability.
• Session Room Preparation:
  • Prepare psychedelic facilitation room per Cybin specifications (comfortable furniture, AV equipment, dual-music transmission, proximity to restroom).
  • Ensure AV recordings and room photos are captured and submitted for sponsor approval.
• Protocol Adherence and Documentation:
  • Comply with all session documentation, assessments, and recording requirements.
  • Participate in monthly site/regional Peer Consultation Groups.
  • Complete and maintain required records in electronic Case Report Forms (eCRFs).

Qualifications and Training Requirements

• Lead Facilitator/Session Monitor:
  • Must be a graduate-level professional licensed for independent therapy practice and credentialed per FDA guidelines.
• Assistant Facilitator/Session Monitor:
  • Same credentials as Lead Facilitator or
  • At least a bachelor’s degree and minimum one year of clinical experience in a licensed mental health setting.
• Training Requirements:
  • Completion of Cybin’s EMBARK Psychedelic Facilitation Model and protocol-specific training.
  • Certified in ICH-GCP (Good Clinical Practice).
  • Trained and acclimated to site’s informed consent process.
  • Must have a completion certificate for all trainings before participation.
• Music and Technology Adherence:
  • Must follow Cybin’s music playlist requirements for dosing sessions, using both headphones and speakers in-room.

Time Commitments

• Session Frequency and Duration:
  • Preparatory sessions: Approximately three per participant per dosing sequence (6 total per participant), each 90 minutes.
  • Dosing sessions: Two per participant (each session up to 8 hours onsite).
  • Integration sessions: Three per participant after each dose (6 total per participant), each 90 minutes.
• Other Workload Expectations:
  • Monthly Peer Consultation Group attendance.
  • Training refreshers as protocol evolves.
  • Room and technology preparation before participant arrival.
  • Ongoing documentation and reporting duties for each session, including adverse event reporting and facilitator-reported events.

Commitment to Study Procedures and Standards

• Facilitators must maintain strict adherence to blinding, confidentiality, and protocol fidelity.
• Commitment to providing ethically rigorous, culturally competent, and trauma-informed care as outlined in the EMBARK framework.
• Requirement to maintain professional conduct and neutrality throughout participant care.
• Obligated to report any issues, protocol non-adherence, or participant safety concerns immediately to clinical leads

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