Clinical Study Assistant

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MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. 

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other.  We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid people. MAPS PBC strives to establish a supportive, equitable and accessible work environment.

Call for Candidates

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The CSA 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. Interested and qualified candidates are encouraged to apply online at: https://tinyurl.com/applyMPBC

 

Location

This is an in-office position in the MAPS PBC headquarters office located in Santa Cruz, CA, or the MAPS PBC satellite office located in Oakland, CA.

 

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 PST). 

 

Minimum Requirements

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

 

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
  • Ability to use the following tools with some training (previous experience a plus): Microsoft Office Applications (Word, Excel, Powerpoint, Outlook, Sharepoint), Smartsheet, Zoom and Asana.

 

General CSA Responsibilities

  •  Provide assistance, where directed by the Associate Director of Clinical Operations and CRA teams, in tasks relating to preparation and review of protocol and protocol related documents or any other clinical functions
  • Assist with database testing
  • Assist in the creation of study materials, including but not limited to documents, presentations, and reports
  • Facilitate in-house filing of required essential documents in the eTMF (Montrium) for study start-up and throughout conduct of study through archiving
  • Assist with document tracking and archiving
  • Assist with document collection from clinical trial sites
  • Maintain study and document tracking tools as appropriate
  • Distribute clinical trial related materials to sites or clinical team members as appropriate
  • Review TMF, track documents as needed and set up for archiving at the end of trials
  • Maintain effective communication with other members of the clinical team
  • Assist with CTMS system
  • Assist with translations of documents
  • Assist with study supply planning, ordering and shipping
  • Participate in team meetings and assist in preparation, sending meeting invites, including management and distribution of meeting minutes
  • Perform administrative tasks to support the Clinical Team and team members as needed
  • Assist with onboarding/offboarding of team members
  • Assist with tracking of training documentation for team members
  • Assist with obtaining signatures through Adobe Sign
  • Escalation of site issues through the proper channels of communications

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1115 Mission Street
Santa Cruz, CA 95060-9989

MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.