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.

Research Assistant

Location: Phoenix, Arizona

Hours: Full-time, 40 hours per week

Reports To: Dr. Suzanne Sisley, Site Principal Investigator

Payroll taxes will be paid by the employer.

Summary:

Support the study staff in performing laboratory duties and unblinded handling of study medication and urine drug tests. Perform regular blood draws and process laboratory samples. Review participant video data and reconciling the video data with the participant log of use during study participants' weekly visits. Package study drug and distribute study drug.

Responsibilities:

  • Meticulous packaging of study drug.
  • Distribution of study drug to participants.
  • Download participant data from handheld devices.
  • Store downloaded data appropriately, maintaining participant confidentiality.
  • Review video data and reconcile with participant logs.
  • Conduct laboratory blood draws and urine tests and process samples appropriately.
  • Assist in trouble-shooting issues with the handheld devices interfacing with participants and the Study Coordinator.
  • Complete needed paperwork associated with data review.
  • Attend meetings and trainings as needed.
  • Provide instructions for use of handheld equipment.

Qualifications:

  • Interest in gaining experience working on a FDA approved clinical trial following ICH/GCP standards.
  • Excellent follow through and time management.
  • Strong communication skills, both verbal and written.
  • Computer-literate, Proficient in MS Office applications.
  • High attention to detail.
  • Ability to prioritize daily workload and follow through productively.
  • Able to mulit-task with strong problem solving skills.
  • Comfortable working independently and as part of a team.
  • Certified in phlebotomy
  • Familiar with ICH GCP
  • Living in the Phoenix area, AZ

About Us:

Investigators are conducting a triple-blind, placebo-controlled study investigating the use of marijuana in treating the symptoms veterans with Posttraumatic Stress Disorder (PTSD). Marijuana is a Schedule 1 controlled substance. This study is sponsored by the Colorado Department of Public Health and Environment and 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.

 

Adherence Rater

We are seeking Adherence Raters who are fluent in English and either Spanish, Dutch, German, or Czech. This is a remote contract position. Pay is $30 per hour.

Job Description:

"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:

  • 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 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.

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

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.

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 amount of experience and years of experience will determine the amount of responsibility. 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:

  • 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.