To apply for a position, please contact This email address is being protected from spambots. You need JavaScript enabled to view it. and submit your resume or CV, along with a cover letter that describes your qualifications, interests, and reasons for applying to MPBC.

Clinical Intern

Location: Santa Cruz, CA

Salary: TBD

Reports to: Clinical Operations Manager

Hours: 20 hours per week between 9:00 AM - 5:00 PM PST

Summary of Position:

The Clinical Intern will assist the clinical research group with general administrative duties necessary to execute clinical research trials. The intern’s responsibilities will include, but are not limited to, filing, document tracking, file migration, document development, and IT Support duties. The Clinical Intern will have the opportunity to learn about Good Clinical Practices (GCP) and standard clinical trial procedures and timelines. This position will offer the chosen applicant a chance to learn a wide array of clinical research terminology and use a variety of different systems. The position will require 40 hours/week.

Role Responsibilities:

  • Become acquainted with MPBC’s standard clinical trial procedures and timelines.
  • Become acquainted with MPBC’s ongoing clinical studies.
  • Assist in maintenance and integration of Montrium electronic trial master file (eTMF) system.
  • Scan, file, and retrieve relevant clinical study documentation.
  • Assist with ongoing clinical systems maintenance and projects.
  • Order, package, and ship study materials to various study sites.
  • Help track regulatory submissions and maintain regulatory correspondence with the FDA.
  • Assist in study document drafting and tracking for various ongoing clinical studies.
  • Provide general assistance to members of the clinical group.
  • Provide internal and external IT support on projects, tasks, and support requests.

Qualifications:

  • Comfortable using PC and Mac platforms.
  • Experience using Microsoft Office Applications (Word, Excel, Outlook).
  • Previous or current college/research experience in a related biological, life, or social science is strongly preferred.
  • Able to navigate through folder structures and files.
  • Excellent communication skills (spoken and written) and the ability to ask coherent questions.
  • Interest in clinical, psychedelic, trauma, and/or harm reduction research.
  • Ability to multi-task and thrive in a fast-paced environment.
  • Have excellent attention to detail and problem-solving skills.
  • Willingness to dedicate time during regular business hours (9:00 AM – 5:00 PM PST), Monday through Friday, at the MAPS office in Santa Cruz, CA.

Physical Requirements:

  • May require carrying packages, up to 30 pounds, up and down stairs.
  • Will require traveling up one set of stairs.

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.

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

Study Coordinator

Location: Boulder, CO

Reports to: Marcela Ot’alora, M.A., L.P.C., Site Principal Investigator

Employment Dates: Ready to begin as soon as possible and work on an annual contract basis for duration of the studies. This position will require work on three MDMA studies – 2 PTSD-oriented and 1 in healthy humans. Studies are expected to last through 2020. Must work in Boulder, Colorado.

Send a resume/CV and cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it..

Hours: 100% full-time employee; hours flexible.

Summary:

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.

Responsibilities:

  • Collaborate within a team throughout the clinic and the Sponsor in order to successfully conduct the clinical trials.
  • Provide support and tracking of fiscal study management, preparing invoices for services and payment.
  • Oversee study operations, filing of essential documents, regulatory documentation and keeping tracking logs up to date.
  • Coordinate all aspects of subject participation associated with trial execution including subject recruitment, appointment making, screening, enrollment, consent, coordinate lab work, coordinate visits with outside raters, track study visits and provide information to team members as needed.
  • Participate in regular team meetings.
  • Ensure general inquiries from current and prospective participants and others are appropriately managed.
  • Maintain Source Records and complete electronic Case Report Form with input from the Investigator.
  • Perform data uploads.
  • Provide on-site support in cases of anomalies or emergencies and ensure timely completion of safety reporting forms.
  • Provide general support for a successful completion of the study.

Minimum Requirements:

  • Bachelor's Degree with at least 2 years of direct clinical research experience.
  • Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP.
  • Knowledge of ICH/GCP guidelines and FDA CFR regulations as they apply to clinical research.
  • Computer skills including experience with electronic CRF systems, competent in Word and spreadsheet applications and proficient in MS Office applications.
  • Living in the Boulder area
  • Able to pass a DEA background check with no record of felony drug charges.

Additional Competencies:

  • Ability to work independently and within a team
  • Ability to work independently and within a team
  • Must be reliable, communicative, and able to be calm under pressure.
  • Compassionate communicator
  • Excellent written and verbal communication skills
  • Confident and influential approach
  • Self-motivating, able to prioritize tasks and take initiative
  • Possess sound judgment, providing appropriate escalation of issues, discretion and be highly detail orientated
  • Strong problem solving skills.
  • Able to lead, motivate and understand the needs of others.
  • Strong organizational skills with attention to timelines.
  • Coordination and planning of multiple tasks with excellent follow through and time management.
  • Recognize potential obstacles and work within set timelines.
  • Conscientious and precise delivery of work even when under pressure.

About Us:

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. This study is sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit, membership-based research and educational organization and is being conducted as a pharmaceutical trial under the jurisdiction of the US FDA. MAPS' mission is 1) to treat conditions for which traditional medicines provide limited relief—such as posttraumatic stress disorder (PTSD), pain, drug dependence, and anxiety and depression associated with end-of-life issues—by developing psychedelics and marijuana into prescription medicines; 2) to cure people by building a network of clinics where treatments can be provided; and 3) to educate the public honestly about the risks and benefits of these drugs.

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

Clinical Medical Writer (CMW)

Location: Santa Cruz, CA

Pay Range: Upon Request

Position Type: Full Time

Exemption Status: Non-exempt

Position Duties:

The Clinical Medical Writer (CMW) will be responsible for supporting the regulatory document writing process and coordinating clinical study report development to develop the global evidence base for MAPS-sponsored research. We are seeking creative individuals who enjoy working within a small, entrepreneurial environment that is mission-driven, results-driven and research-oriented. The CMW will fulfill the following job responsibilities:

Responsibilities:

  • Become acquainted with MPBC’s standard clinical trial procedures and timelines.
  • Writes, formats, reviews or QC checks the following documents: Clinical study reports, Clinical study protocols, Investigator Brochures, Investigational New Drug (IND) submissions, clinical summaries, selected publications, annual reports, and documents contained in the modules of the Common Technical Document (CTD).
  • Participates in developing global medical writing strategy
  • Takes responsibility for ensuring timely execution of medical writing strategy and operating plans. Regularly reports to supervisor on progress against objectives and plans.
  • Plans and leads clinical writing projects and builds cross-functional relationships
  • Provides technical guidance to project teams and assists with interpretation/presentation of clinical efficacy and safety data
  • Reviews existing scientific literature, and writes clinical, data-driven summaries when requested.
  • Ensures relevant clinical trial information is uploaded onto ClinicalTrials.gov and EudraCT in accordance with regulatory requirements and company SOPs.
  • Develops and applies best practices in compliance with relevant regulations and legislation and ensures that company documentation meets with these standards.
  • Contributes to manuscripts for submission to peer-review journals, conference abstracts, posters and presentations as needed.
  • Interfaces with Quality/Compliance, Regulatory Affairs, Clinical Operations, Data Science and the Independent Statistical Group.

Minimum Requirements:

  • Research experience required, clinical research experience highly preferred
  • Bachelor’s degree or higher in related scientific field and at least 3 years of professional experience as a medical writer in the pharmaceutical, biotech, or medical device industry.
  • Proficient knowledge of medical terminology, psychiatric diseases, pharmacology, pharmacodynamics, and research
  • Strong understanding of statistical testing models and data interpretation
  • Knowledge of and ability to describe highly-technical research methodology and results (including clinical investigation design and biostatistics) in written format
  • Strong understanding of global regulatory requirements that pertain to clinical trial conduct and medical writing
  • Experienced in searching relevant data bases (e.g. Emabase, PubMed and Medline) to be able to complete through systemic literature reviews and clinical summaries
  • Working experience with clinical outcomes research study design
  • Strong knowledge of Good Clinical Practices, ICH guidelines, European Medicine Agency practices, Good Publication Practices, and global clinical regulations, including FDA regulations
  • Ability to self-manage workload, project manage cross-functional teams, and meet aggressive timelines
  • Comprehensive computer skills, particularly in the use of Microsoft suite, Smartsheet
  • Ability to interpret datasets that have been provided is SAS and SPSS formats
  • High level of numeracy, specifically in the interpretation of statistical analyses of scientific data
  • Knowledge of project management
  • Proficient with cloud-based computer systems

Additional Competencies:

  • Ability to work independently and within a team
  • Open and clear communicator
  • Excellent written and verbal communication skills
  • A demonstrated appreciation for psychedelic research with high attention to detail and accuracy
  • Strong interpersonal skills including communication, collaboration and negotiation capabilities.
  • Ability to independently set and manage multiple competing priorities while guiding others.
  • Ability to exercise good judgment in a variety of situations, with strong written and verbal communication, organizational skills, and the ability to maintain a realistic balance among multiple priorities.
  • Ability to work under pressure at times to handle a wide variety of activities and meet internal and regulatory timelines.
  • Strong critical thinking and analytical skills with proficiency in managing multiple tasks.
  • Demonstrated ability to identify issues and implement solutions, including identifying and involving the appropriate decision makers.
  • An advanced degree in science, medicine, or dentistry is preferred.

Additional Competencies:

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, clinical regulatory affairs, publications, and clinical data. MPBC's primary work is completing Phase 1/2/3 studies of MDMA-assisted psychotherapy for PTSD required to develop MDMA-assisted psychotherapy into an approved treatment for PTSD. MPBC also conducts research involving a number of psychedelic drugs for the treatment or symptom management of various chronic psychiatric disorders.

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Clinical Research Associate - Site Monitor

We are seeking a Clinical Research Associate/Site Monitor to support the MAPS Public Benefit Corp (MPBC) and work from our office in Santa Cruz, CA or from home in the greater Bay Area.

CRA Level: I and II

Hours: 40 per week

Exemption status: Exempt

Position Duties:

To 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. The CRA is responsible for managing, implementing and monitoring clinical studies in a team setting. The CRA 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 from source documents, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s). CRA Monitor responsibilities include: manage assigned clinical study protocols and amendments; track deviations; manage clinical trial sites and assure timely initiation and completion of clinical studies. The focus of the CRA monitor role is acting as the point of contact for assigned clinical site(s) and monitoring the assigned site(s) under direction of the Clinical Operations Manager.

Minimum Requirements:

A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of Bachelor degree preferred. The CRA monitor role applies to both level I and II CRAs, the amount of experience and years of experience will determine the amount of responsibility and the CRA level. A minimum of 2 years CRA experience (CRA I) or 1 years CRA experience (CRA II). Knowledge of medical practice/techniques and terminology. Knowledge of U.S. regulations governing clinical trials.

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 lead, motivate and 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
  • Be proactive in problem solving

Description of Responsibilities: General CRA I-II Responsibilities

  • Provide assistance, where directed by the Clinical Operations Manager, in tasks relating to preparation and review of protocol and protocol related documents
  • Assist in design of ICFs, CRFs, Source Records
  • Assist in study supply planning
  • Assist in tracking budgets
  • Assist with preparation of regulatory submissions
  • Assist clinical sites with IRB/IEC submissions and ensure collection of required essential documents for study start-up and throughout conduct of study.
  • Maintain effective communication with other members of the clinical team and management.
  • Assist in Identifying sites, conduct pre-study meetings and advise the team of suitability of sites.
  • Conduct study initiation, monitoring and close-out visits as specified in the monitoring plan and protocol to ensure subject safety. Prepare training material as appropriate.
  • Liaise with investigators on conducting the trial under the guidance of the clinical team.
  • Provide a report, as required, of the status assigned studies, and make any necessary recommendations for contingency planning.
  • Ensuring each centre has the trial materials and training the site staff to trial-specific industry standards.
  • Verify that data entered into the electronic CRFs is consistent with participant source documents, known as Source Document Verification (SDV).
  • Review study data and assist with cleaning and locking clinical trial databases.
  • Archive study documentation and correspondence.
  • Assist the team in preparing final reports.

Specific Monitoring Responsibilities:
Travel is required as needed by the study enrollment rate.

  • Ensure all personnel at study sites are appropriately informed and trained at study initiation and that it is adequately maintained throughout the study. This will include orientation, training and monitoring of:

  • - Protocol details including any special efficiency or safety measurements
    - Source Document Verification requirements
    - Adverse Event (AE) and Serious Adverse Event (SAE) reporting
    - Case Record Form completion
    - Patient Information Sheets and Informed Consent
    - Ethical Committee requirements
    - Supplies, storage and drug accountability
    - Video equipment and handling of recordings
    - Good Clinical Practice
  • Act as the main line of communication between the sponsor and the investigator. Make regular contact with investigators or site staff during the course of studies, to ensure protocols are proceeding in an appropriate manner.
  • Lead meetings with sites as needed providing meeting notes and follow through on action items.
  • Verify that the investigator follows the approved protocol and all GCP procedures. Maintain familiarity of local regulatory requirements, MAPS SOPs, guidelines and ICH Good Clinical Practice.
  • Verify that source data and other trial records are accurate, complete, and maintained.
  • Collect completed CRFs, track them and deliver them to the Sponsor.
  • Write visit reports.
  • File, collate and track documentation for the Trial Master File.
  • Review, track and resolve any data queries/protocol deviations prior to database lock.
  • Ensure AEs, SAEs, reactions, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs and the SAE Database.
  • Ensure timely reporting of important AEs and SAEs
  • Track study progress using tracking tools, ensuring timely and quality updates.
  • Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements.
  • Ensure all unused trial supplies are accounted for.
  • Close down study centers on completion of the trial.

Submit a resume and cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it.