TMF Associate - Remote

Data Management and Services · Any City, Any State, California
Department Data Management and Services
Employment Type Full-Time
Minimum Experience Mid-level

About MAPS Public Benefit Corporation (MAPS PBC)

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. MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) nonprofit that is at the forefront of the rapidly growing psychedelic medicine industry and movement and is a leading advocate for drug policy reform. 

 

MAPS PBC’s current focus is developing MDMA-assisted therapy as a breakthrough treatment for PTSD with plans to submit for FDA approval in 2022. In May 2021, the results of our successful Phase 3 clinical trial were published in Nature Medicine and profiled on the front page of The New York Times

 

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. 

 

Why work for MAPS Public Benefit Corporation (MAPS PBC)?

MAPS PBC is a dispersed workforce that offers full-time employment in a dynamic remote work environment. This means our employees enjoy competitive salaries and benefits packages, as well as the comfort of working from their own homes. Through the conscious use of technology, we stay connected to our team members and professional community while, at the same time, enjoying the freedom of a remote environment.

 

We are committed to conscious leadership and an inclusive team dynamic. Our culture is one of mutual respect, responsibility, and trust. Our employees’ health and happiness are priorities, and we treat our staff like people, not numbers on a spreadsheet.

 

MAPS PBC is at the forefront of changing the way mental health issues are treated and is committed to bringing dignity and access to overcoming mental health challenges through the conscious use of psychedelics. We believe we are changing the world, and we want you to be a part of it.

 

Position Summary

Reporting to the Systems Manager on the GxP eSystems Team in the Department of Data Management & Services, the Trial Master File (TMF) Associate is primarily responsible for filing of auditable regulatory document filing on paper TMF and in the Montrium eTMF for clinical trials. This position also supports TMF clean-up efforts and inspection readiness of Essential Documents to support clinical trials.


The TMF Associate must enjoy working in a small, entrepreneurial environment that is mission- driven, results-focused, and research-oriented.

 

Location

This position will be fully remote, with Santa Cruz candidates preferred. Secure internet and reliable phone reception are required while working remote. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Occasional travel may be required.

 

Hours

Full-time. We are a West Coast-based company with an office in Santa Cruz, California and applicants must be available during normal business hours (9:00AM - 6:00 PM Pacific Time, Monday through Friday). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Minimum Requirements

  • A bachelor’s degree in the biomedical sciences or a related field, or relevant experience with a strong interest in clinical research
  • Familiar with Good Clinical Practices
  • Demonstrated willingness to stay abreast of development in the area of professional competence

 

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.


Description of Responsibilities

  • Primarily responsible for filing of auditable documents in the Montrium eTMF
  • Supports reconciliation of paper TMFs per regulatory standards for Essential Documents
  • Generate document reports and resolve clean-up issues
  • Documentation development under supervision of application manager, as needed
  • Smartsheet and Asana support
  • Support document inventory management


FLSA Status

Non Exempt (this position is eligible for overtime)

 

Compensation

Hourly compensation commensurate with experience. Eligible for overtime; competitive benefit package includes:

  • Paid Time Off (PTO)
  • Sick Time
  • Holiday Pay
  • Employer paid medical, dental, vision, and life insurance (100% covered for employees + 50% for dependents)
  • Employer funded mental health HRA
  • Employer funded SEP IRA
  • FSA/Dep Care
  • Pet Insurance
  • Home Office Stipend
  • Wellness Wednesday/Journal Club/Yoga/Meditation and so much more!

Thank You

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  • Location
    Any City, Any State, California
  • Department
    Data Management and Services
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level