Clinical Research Rater

Job Description

Job Description

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