MAPS/MPBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS/MPBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Drug Development Assistant

Location: Remote position. East Coast preferred.

Hours: Full-time

Salary: TBD

Summary of Position:

To assist the Drug Development Team in ensuring that clinical and commercial drug supplies are forecasted, manufactured (through third party vendors) and managed in line with program-wide timelines, strategy and in accordance with relevant Standard Operating Procedures (SOPs), the principles of appropriate GxPs and all other applicable regulations governing medicines for human use. The DDA must enjoy working in a small, entrepreneurial environment that is mission-driven, results-driven, and research-oriented. The DDA will assist in reviewing applicable regulatory guidelines, clinical supplies planning, management, inventory, distribution, timelines, and specifications documents creation and review including essential document filing. The DDA will become familiar with all aspects of drug development, GxP guidelines and related FDA/ROW regulations, and will have the opportunity to work in a team environment under direction of the Drug Development Lead reporting to the Director of Research Development and Regulatory Affairs within the Department of Research Development and Regulatory Affairs.

Minimum Requirements:

A scientific degree or relevant experience with a strong interest in drug development and clinical research. Minimum of Bachelor degree is required. Knowledge of applicable regulatory frameworks and experience with project management concepts and actvities and willingness to stay abreast of development in the area of professional competence. East coast preferred, full-time remote position.

Additional Competencies:

  • Ability to work independently and within a team
  • Open and clear communicator
  • Excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize and take initiative
  • Make informed decisions based on guidance from manager and take responsibility for actions
  • Possess sound judgment, discretion and be detail orientated
  • Able to understand the needs of others
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Computer skills, facility with word-processing, spreadsheet and project management applications
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure
  • Demonstrates results-oriented approach, determination, owns responsibility, and accountability
  • Functions as a team member and follows direction of the Drug Development Lead

Qualifications:

  • Assist with forecasting of IMP supply needs in collaboration with Senior Management and Clinical Operations
  • Assist coordinating and managing packaging/labelling requirements for US and non-US clinical trials
  • Assist with inventory management across multiple vendors and depots
  • Manage IMP shipments to domestic/international clinical sites and third-party investigators according to current processes and associated SOPs/WIs
  • Support SOP review, updates and formatting
  • Oversight and filling of all study related IMP essential documents within the respective eTMFs
  • Supports eCTD submissions to regulatory agencies using ARIM, Web Trader, Eudralink and EudraCT
  • Attendance at vendor project management calls and follow-up related to minutes, action items and decision logs, as applicable
  • Coordination of vendor documents review and approval with Senior Management and external consultants as needed
  • Assist with vendor contracts tracking and program/study budget/cost projections
  • Assist with vendor identification, SOW planning, review and development
  • Assist with creation of study specific IMP related plans, logs and processes according to established SOPs and templates
  • Assist with maintaining clinical team training documents
  • Assist in the creation of IMP related study training materials
  • Distribute IMP clinical trial related materials to sites or clinical team members as appropriate
  • Maintain effective communication with other members of the drug development and clinical teams
  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • Perform administrative tasks to support the Drug Development Team members as needed

To apply, email This email address is being protected from spambots. You need JavaScript enabled to view it..

Quality Intern (QI)

Location: Santa Cruz, CA

Salary: DOE

Hours: Full-Time, 30-40 hours per week

Exemption Status: Non-exempt

Summary of Position:

To assist the Quality Team in the Department of Research Development and Regulatory Affairs (DORDARA) in ensuring that quality activities 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. The QI will assist in reviewing regulatory guidelines, archival and retention plans, reporting, clinical document preparation, including quality control, formatting, content review, document assembly, data verification, version control, essential document filing and reference management. The QI will become familiar with the clinical trial process, ICH-GCP guidelines and FDA regulations pertaining to Quality Systems, and will have the opportunity to work in a team environment under direction of the Clinical Systems and Quality Manager.

Minimum Requirements:

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Bachelor degree preferred. Knowledge of regulatory frameworks, medical practice/techniques and terminology are a plus.

Additional Competencies:

  • Ability to work independently and within a team
  • Open and clear communicator
  • Excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize and take initiative
  • Make informed decisions based on guidance from manager and take responsibility for actions
  • Possess sound judgment, discretion and be detail orientated
  • Able to understand the needs of others
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Computer skills, facility with word-processing and spreadsheet applications
  • Coordination and planning of tasks and time management
  • Recognize potential obstacles and work within set timelines
  • Conscientious and precise delivery of work even when under pressure

Description of Responsibilities:

  • Provide assistance, where directed by the Clinical Systems & Quality Manager, in tasks relating to preparation and review of clinical documents and SOPs
  • Assist with data entry in Quality Management System
  • Assist with maintaining clinical team training documents
  • Facilitate in-house filing of required essential documents in the TMF throughout conduct of study
  • Distribute clinical trial related materials to sites or clinical team members as appropriate
  • Review TMF during studies and for completion for archiving at the end of trials
  • Maintain effective communication with other members of the clinical team
  • Assist with CTMS system
  • Assist with eTMF system
  • Participate in team meetings and assist in preparation, calendaring and management of meeting minutes
  • Perform administrative tasks to support the Quality Team and DORDARA staff as needed

To apply, email This email address is being protected from spambots. You need JavaScript enabled to view it..

Training Coordinator

Location: This is a remote position. A suitable home office is required, with a private and quiet area to work that is free from distraction. A clean desk space, secure internet, and reliable phone reception are required. The duties of this position include frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in California. The MAPS PBC headquarters office is located in Santa Cruz, CA. Occasional travel may be required.

Compensation: This position is non-exempt. Hourly compensation range is $17.00-$20.00, depending on experience.

Hours: Full-time, 40 hours per week. Applicants must be available 40 hours a week, during normal business hours (9:00 AM - 6:00 PM Monday-Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

Manager: Shannon Carlin, M.A.

Call for Candidates:

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Training and Supervision team. The Training Coordinator plays a major role in supporting trainees through the MDMA Therapy Training Program. This position requires someone excited to engage with people, able to work well in a fast environment, and adept at organizing and managing lots of information online. Interested and qualified candidates are encouraged to apply online at: tinyurl.com/applyMPBC

Candidates who applied for the previous Admissions Coordinator position in the last four months will automatically be considered for this opening and do not need to submit a new application. People of color, transgender, lesbian, gay, and bisexual people are strongly encouraged to apply.

Position Duties:

Coordinate the operation of the MDMA Therapy Training Program.

  • Support trainees in their progress through the training program.
  • Track training enrollment, progress, completion, certification and recertification, via database and online file share
  • Collaborate with other staff members on the process of trainee enrollment, tuition and course registration
  • Communicate with trainees via regular online communication, including email, online forum, informational and supportive documents, and answer questions and proactively support trainees
  • Event planning for national and international week-long training retreat events, each hosting 60 or more people, including coordinating venue contracts, vendor relationships, lodging, meals, some travel arrangements, and venue logistics such as audio-visual equipment rentals, meeting agenda, ordering supplies and printing, décor, and planned activities
  • Coordinate event registration, creating and managing registration forms, lodging assignments, meal preferences, and transportation
  • Support Trainers in retreat logistics, preparation and follow-up.
  • Meet with trainees to support personalized training plans and address experiential requirements of program
  • Provide detailed instruction for various training components. Support each trainee and team in responding to unique needs.
  • Coordinate with Supervisors to facilitate Supervision requirement of training and confirm certificate eligibility. Work alongside Clinical Operations staff in concerted effort to support site development of therapy clinics and groups of trainees
  • Contribute to public communications: email newsletter, web content, informational calls and documents
  • Schedule meetings, track multiple calendars, take meeting minutes
  • Occasionally assist in the delivery of public presentations
  • Meet regularly with MAPS PBC staff, trainees, and the public via online platforms
  • Report to manager weekly and participate in regular meetings on the project, department, and organizational level
  • Manage project tasks on Asana and contribute to project management
  • Create feedback surveys and analyze results for program improvements
  • Contribute to Training and Supervision Department planning and goals

Minimum Requirements:

3+ years’ experience in administration, preferably in an education setting. Excellent computer and online organizational skills. Preferred familiarity with the mental health field. Awareness of MDMA-assisted psychotherapy and psychedelic research.

Additional Competencies:

  • This remote position requires a highly motivated and organized person who follows through on assignments with attention to detail
  • Excellent oral and written communication skills
  • Compassionate customer service skills, enjoys interacting with many people nationally and internationally
  • Ability to ask clear, goal-oriented questions
  • Excellent problem-solving skills with a focus on creating solutions
  • Self-motivated to complete tasks within agreed-upon deadline, ability to communicate clearly about deadlines and expectations
  • Ability to manage time well and ask for support when needed
  • Self-reflective and committed to ongoing growth and improvement
  • Embodies discretion and able to handle information with sensitivity and confidentiality
  • Quick learner, excited about learning to use systems in new contexts
  • Comfortable navigating Mac and PC operating systems
  • Comfortable using internet applications
  • Ability to support the following tools with some training (previous experience a plus): Microsoft Office Applications (Word, Excel, Outlook, Sharepoint), Smartsheet, Zoom, Asana, AWS, Moodle, Medrio, Google Forms, online surveys, Mailchimp, CRM database, spreadsheets

General Responsibilities:

  • Communicate and collaborate with key players, internal and external staff
  • Check in regularly with Manager and complete assignments by agreed deadline
  • Document process and provide regular updates
  • Proactively seek methods of improvement, of individual work and project outcomes
  • Proactively work to streamline work flows, build efficiency, security and user interface of various platforms

To apply, visit tinyurl.com/applyMPBC.

Adherence Rater

Candidates must be bilingual in English and one of the following languages: Portuguese, Finnish, and Norwegian.

“Treatment fidelity is the ongoing assessment, monitoring, and enhancement of the reliability and internal validity of a study (1). Treatment fidelity helps to increase scientific confidence that the changes in the dependent variable (outcome of interest) are due to manipulations of the independent variable…”

- Borrelli, B. (2011). The Assessment, Monitoring, and Enhancement of Treatment Fidelity In Public Health Clinical Trials. Journal of Public Health Dentistry, 71(s1), S52–S63. http://doi.org/10.1111/j.1752-7325.2011.00233.x

Adherence Raters support MAPS-sponsored MDMA-assisted psychotherapy trials, by assessing treatment integrity. Trained Adherence Raters view recorded therapy sessions and rate provider competence and adherence to the treatment method based on defined criteria.

Adherence Rater Qualifications:

Due to the specialized and sensitive nature of the work that is involved, it is important for an Adherence Rater to have the proper qualifications. The ideal background for an Adherence Rater would be someone eager to learn about MDMA-assisted psychotherapy, who is either a licensed therapist or in training to be a licensed therapist. The following qualifications are deemed essential:

  • Motivation for self-development in the therapeutic field
  • Eagerness to learn about MDMA-assisted psychotherapy
  • Formal, graduate-level training in psychotherapy
  • Licensed as a therapist or training to be a licensed therapist
  • Psychotherapy internship or equivalent experience with direct patient contact
  • One year of experience working with trauma population or equivalent
  • Training in the sensitive and confidential nature of the subject material
  • High-level of openness to feedback
  • Discrete access to the Internet in a private setting on a personal computer
  • Completion of MAPS Adherence Rater training

Applicants are referred to Adherence Trainers who screen CVs and assess qualifications for essential requirements. Only those applicants meeting the requirements will be accepted for training. Applicants accepted for training will receive access to training materials, any additional instructions, and an invitation to an upcoming instructional session.

Adherence Rater Training:

Before reviewing video sessions, prospective Adherence Rater Trainees must submit a CV, a signed Confidentiality Agreement, and documentation of HIPAA certification to the Sponsor. Once each training module is completed and relevant documents are filed, Adherence Rater Trainees can begin rating session video. Before becoming a fully certified Adherence Rater, new Adherence Rater Trainees will need to address each of the following training modules:

Minimum Requirements:

3+ years’ experience in administration, preferably in an education setting. Excellent computer and online organizational skills. Preferred familiarity with the mental health field. Awareness of MDMA-assisted psychotherapy and psychedelic research.

Additional Competencies:

  • Read the Therapist Treatment Manual: “A Manual for MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder”
  • Read the Adherence Manual “MDMA-Assisted Psychotherapy Adherence and Competence Ratings Manual”
  • Watch the Mithoefers’ Workshop “Principles of Psychedelic Psychotherapy-Lessons from MDMA Research for PTSD”
  • Complete the HIPAA Tutorial (http://irb.ucsd.edu/hipaatutorial/login.html)
  • Attend an in-person instructor-led training session and rate the presented video
  • Complete the Inter-rater Reliability Process, which involves calibration Adherence and Competence ratings and trainer feedback
  • Complete the Adherence and Competence Rater Training Checklist

Primary Adherence Rater Duties:

Adherence Raters complete all Adherence Rater trainings, establish Inter-rater Reliability, and report to Adherence Rater Managers as assigned. Adherence Raters are tasked with the following roles and responsibilities:

  • Watching and coding video
  • Completing Source Records containing ratings and relevant feedback by due date
  • Being available for a comment period lasting two weeks after Rating submission
  • Attending ongoing administrative supervision meetings and check-ins
  • Working with other Adherence Raters as part of self-care team
  • Ongoing cohesive communication with other Adherence Raters and Managers
  • Ensuring technical set-up is maintained to privately view videos

Inter-rater Reliability Process

The Inter-rater Reliability process is designed to standardize the assignment of ratings to ensure that Adherence Raters are applying the method consistently. Calibration video sessions will be selected by the Sponsor Supervisor and scored by all available Adherence Raters. These ratings will be converted into quantitative data and correlated to the ratings scores of a Senior Adherence Rater Manager, whose ratings serve as a “gold standard”. The Sponsor Supervisor will examine the variability in the data to identify items that need to be discussed with Trainees. This process can be repeated, on an individual basis or by the group, as many times as necessary, until each Trainee is reliable.

Adherence Rater Trainees must rate at least three video sessions (one preparatory, one experimental, and one integrative session) that have been rated by the gold standard. The Cohen’s Kappa (κ) must be greater than or equal to 0.50 to establish Inter-rater Reliability. Adherence Rater Trainees who provide ratings that do not meet the criteria (κ ≥ 0.50) shall complete a second set of three ratings, to be included in a subsequent correlation analysis for comparison to the gold standard ratings. Any Trainee who is unable to establish Inter-rater Reliability after two rounds of Kappa analysis must complete additional training in order to continue in the training program.

To apply, email your CV to This email address is being protected from spambots. You need JavaScript enabled to view it..

About Us:

MAPS Public Benefit Corporation (MPBC) is the wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) that was established in 2014. MPBC manages the clinical research program and oversees clinical trial operations, regulatory sciences, clinical publications, and clinical data management. MPBC’s primary work is completing Phase 2 studies of MDMA-assisted psychotherapy for PTSD, and preparing for the Phase 3 clinical trials required to develop MDMA-assisted psychotherapy into an approved treatment for PTSD. MPBC also manages a wide variety of clinical studies aimed at providing a medical context for the use of psychedelics in healing.