Study Coordination & Compliance

• Coordinate daily trial activities in accordance with the study protocol, GCP, ICH guidelines, and institutional policies.

• Maintain accurate and timely source documentation, case report forms (CRFs), and electronic data capture systems.

• Assist in the preparation and submission of regulatory documents (IRB/EC, FDA, DEA, Health Canada, etc.) and ensure ongoing compliance with all approvals.

• Ensure study drug accountability, including receipt, storage, dispensing, and reconciliation of psychedelic investigational products under controlled substance regulations.

Participant Management

• Recruit, screen, and consent participants, ensuring comprehension and voluntary participation in accordance with ethical guidelines.
• Schedule and coordinate study visits, including baseline assessments, preparatory sessions, dosing sessions, and integration follow-ups.
• Monitor participant safety before, during, and after psychedelic sessions, documenting adverse events and escalating as appropriate.
• Serve as a consistent point of contact for participants, fostering trust and confidentiality throughout the study.

Data & Documentation

• Enter and verify study data in electronic data capture (EDC) systems; perform quality checks and resolve queries promptly.

• Maintain essential documents and study files in compliance with sponsor and regulatory requirements.

• Assist with monitoring visits, audits, and inspections; address findings and implement corrective actions as needed.

Collaboration

• Work closely with investigators, therapists, nurses, and other study team members to ensure seamless study conduct.

• Attend investigator meetings, protocol training, and team debriefs to stay aligned with study objectives and procedures.

• Support communication with sponsors, CROs, and regulatory bodies as required.