In Boulder, Colorado, Investigators are conducting a randomized, double-blind, placebo-controlled, multi-site phase 1 study to assess psychological effects of MDMA when administered to healthy volunteers (MT1).
In Denver, Colorado, Investigators are conducting an open-label, multi-site phase 2 study of the safety and feasibility of MDMA-assisted psychotherapy for eating disorders (MED1).
MDMA is a Schedule 1 controlled substance. These studies are sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit, membership-based research and educational organization and are being conducted as pharmaceutical trials under the jurisdiction of the U.S. 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.
Ready to begin December 2020 and work on contract basis for duration of the MT1 and MED1 studies (~2 years+).
HOURS: MT1 Study: Part time, on site in Boulder, Colorado, 2-3 days/(16-24 hrs.) per week. MED1 Study: Part time, on site in Denver, Colorado, 2 days/(16 hrs.) per week.
The individual in this position is responsible for the professional execution of clinical
research activities under the direction of the Site Clinical Investigator and the Sponsor. This position is a shared part-time position for two separate research clinics in Colorado. The candidate must be willing to commute to the Boulder, Colorado site for 2-3 days a week, and commute to the Denver, Colorado site for 2 days per week.
- Collaborate within a team throughout the clinic and the Sponsor in order to successfully conduct the clinical trial.
- 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.
- Bachelor’s Degree with at least 1 year of 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 or Denver area
- Able to pass a DEA background check with no record of felony drug charges.
- 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 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.