Job overview:

The Clinical Care Operations department at Compass leads and oversees implementation of necessary trainings of personnel at clinical trial sites to deliver psychedelic treatment to trial participants. The Associate Manager, Clinical Care Operations will play an important role in the startup and ongoing support of our clinical trials by managing operations to train support providers working on our clinical trials. Support providers are integral in preparing participants for their COMP360 treatment sessions, providing monitoring and support during the sessions, and then supporting the participant’s self-directed integration (or processing) of their experiences. This position will work directly with our trainers and CRO partners, as well as with key internal stakeholders. This position will be responsible for scheduling, running, supporting, and documenting training completion for support providers at clinical trial sites across North America, Europe and Australia. Flexibility to work across time zones, attention to detail, strong initiative, teamwork and sense of accountability will be important in this role.

Location:Hybrid in our Jersey City office or remote on the East Coast in the United States.

Reports to:Associate Director, Clinical Care Operations.

Roles and responsibilities (Include but are not limited to):

• Schedule training events across time zones
• Support smooth operations for live online trainings
• Partner with trainers and CRO to ensure on-time training completion and training documentation
• Oversight of CRO training activities, as assigned
• Assess support provider competency during training, ensuring alignment with the training requirements, and escalating any concerns to clinical and operational leadership as needed
• Manage updates to support provider training materials, including project management, content drafting, managing consultant work, coordination of stakeholder review, and making updates on the Rise e-learning authoring tool used for training content
• Oversight of CRO training activities, as assigned
• Support inspection readiness through adherence to processes, as well as timely, accurate and complete documentation of training activities
• Additional tasks as determined by R&D Operations team
• Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety, data integrity, and accuracy throughout the trial process

Candidate Profile:

• 3-5 years of experience in clinical research operations or training operations in a clinical research setting, Pharma/Biotech, CRO, EdTech or mental health startup
• Experience scheduling events/meetings across time-zones as well as consultant/vendor management and/or customer service required
• Strong excel skills and experience with project management software such as Smartsheet, Trello, or Jira required
• Experience managing events with Zoom (ie. scheduling settings, managing breakout rooms, sharing video/audio) preferred. Experience with the Rise e-learning authoring tool and audio/video editing software preferred
• Experience with complex record keeping in a highly regulated setting required; experience with Quality Management Systems and eTMF filing as well as knowledge of, and experience working with, GDocP strongly preferred
• Highly operational and detail-oriented, able to get things done quickly while ensuring attention to detail and clear communication
• Thrives in a fast paced and continually changing environment with drive to take initiative and commitment to collaboration
• Ability to work flexible hours occasionally to support training across time zones
• Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulation
• Bachelor’s degree, preferrable in life or social sciences areas or equivalent experience