Who We Are

For over 20 years, faculty leading the Johns Hopkins Center for Psychedelic and Consciousness Research have been conducting field-defining human research with psychedelics. At the Center for Psychedelic and Consciousness Research, researchers focus on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health.   

Position Summary

The Sr. Compliance Monitoring Specialist will take the lead on compliance monitoring and regulatory management of several clinical trials involving the administration of psychoactive controlled substances to both healthy and patient populations. The Sr. Compliance Monitoring Specialist will ensure the quality, accuracy, and integrity of clinical trial data and regulatory documents throughout the full lifecycle of multiple clinical trials.

Brief Job Overview

The Senior Compliance Monitoring Specialist responsibilities include: 

 - Managing study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.

 - Participating in risk assessments by reviewing studies for quality assurance and general content.

 - Developing standard and protocol-specific forms, trial-specific monitoring plans, and SOPs.

 - Ensuring the collection and maintenance of required essential documents.

 - Help study staff prepare for external audits. Plan and participate in unscheduled internal reviews and compliance monitoring reviews on an as-needed basis.

 - Generate monitoring summary reports and communicate these findings to Investigators and Research Staff.

Qualifications

- BA/BS in medical research or scientific discipline, health care related, or other appropriate discipline preferred.

- Minimum 5 years of experience with clinical trials/medical research required.

- Certified Clinical Research Associate (CCRA) credentialing is preferred.    

- Experience with quality assurance or clinical trial auditing/monitoring, and/or good clinical practice preferred.

About Johns Hopkins Center for Psychedelic and Consciousness Research

The Johns Hopkins Center for Psychedelic and Consciousness Research is one of the world's leading institutions researching the therapeutic benefits of psychedelics. Our research focuses on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health.

Connections working at Johns Hopkins Center for Psychedelic and Consciousness Research