Remote / FTE
Furthering MAPS Public Benefit Corporation’s clinical development program by assisting in the design, conduct, and safety review of clinical trials. The Medical Monitor is responsible for reviewing safety data and ensuring the safety of study participants in clinical studies in a team setting while working throughout the product’s lifecycle. Helping to ensure that products are utilized effectively, serving as a scientific peer and providing resources within the medical community and are scientific experts to internal colleagues as needed. The Medical Monitor has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s). The focus of the Medical Monitor role is supporting safety review by the Safety Review Committee for all clinical trials, from responding to site questions, reviewing of participant enrollment packets, safety data line listing review, safety information review in documents, safety monitoring at local sites and engaging Key Opinion Leaders and Clinical Investigators under the direction of the Medical Director and the guidance of the Chief Medical Officer and the Director of Clinical Operations.
Administrative Assistant for Clinical Operations
Santa Cruz, CA. / Oakland satellite office / FTE
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The Admin role will report to the Director of Clinical Operations and will administratively support the Clinical Operations team. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually.
Adherence and Supervision Coordinator
Remote / FTE
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Training & Supervision Department. Reporting to the Director of Training and Supervision, the Adherence and Supervision Coordinator supports programs and staff who monitor the delivery of MDMA-assisted psychotherapy for PTSD in MAPS protocols. This position requires competence in program coordination, project management, remote work environments, communication, meeting facilitation, team building, scheduling, contracts, creation and management of spreadsheets. Due to the sensitive and protected nature of psychotherapy clinical trials and clinical supervision, this position requires an individual who respects and is able to uphold confidentiality. Training in HIPAA and Good Clinical Practice will be provided on the job. Preferably the person filling this position will have worked in clinical research and/or mental health settings. The ideal candidate is engaged in therapeutic and self-care practices, is familiar with the process of clinical supervision and the conduct of psychotherapy. Suitable candidates are able to work well in a fast-paced environment and excel at organizing and managing lots of information virtually.
Video Systems Support Specialist (EU)
Remote / FTE
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Training & Supervision Department. The Video Systems Support Specialist plays an important role in collecting, processing, and providing content to MAPS PBC staff and contractors using custom software tools. This position requires competence in video systems and hardware, coding, software development, web security, patient confidentiality, organizational documentation and technical troubleshooting. Suitable candidates are able to work well in a fast environment and adept at organizing and managing complex information virtually.
Clinical Study Assistant
Santa Cruz, California / FTE
CMC and Project Management Assistant (CPMA)
Remote / FTE
Reporting to the Director of CMC and Project Management, the CPMA assists the CMC and Project Management team with document management, including writing, formatting, version control, change control/tracking, and filing. These activities will support all functional areas covered by the CMC and Project Management team which include: clinical and commercial CMC for regulatory submissions, IMP supplies, IMP logistics, IMP project management and inventory, vendor management, nonclinical toxicology, randomization systems, cross-functional program project management, clinical program project management, cross functional inspection readiness support and NDA project management.
Clinical Research Associate
Remote / FTE
MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The CRA role will report to the Associate Director of Clinical Operations and will ensure that clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), the principles of ICH/Good Clinical Practice and all applicable regulations governing the conduct of clinical trials. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually.
Investigators are conducting a randomized, double-blind, placebo-controlled, multi-site phase 3 study of the efficacy and safety of manualized MDMA-assisted psychotherapy for the treatment of severe posttraumatic stress disorder. MDMA is a Schedule 1 controlled substance. The individual in this position is responsible for the professional execution of clinical research activities under the direction of the Site Principal Investigator and the Sponsor.