Full Time
Remote
Posted 1 month ago

MAPS PBC is pioneering a new form of mental health care, beginning with the development of MDMA-assisted therapy as an FDA-approved treatment for PTSD.  MDMA-assisted therapy is a new paradigm in the treatment of mental health, combining a medicine with psychotherapy to address the root causes of PTSD. It has been designated a Breakthrough Therapy by the FDA and the results of our pivotal Phase 3 clinical trial were published in Nature Medicine or profiled on the front page of The New York Times.  

MAPS PBC is a Public Benefit Corporation, with a dual mandate to generate shareholder value and public benefit. We are a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit working for over three decades to develop medical, legal, and cultural contexts for people to benefit from psychedelics. We are committed to continuing to lead the field of psychedelic medicine with integrity and ethics at the core.  

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

  • We are a diverse team that shares a deep belief in the critical need for innovation and expanded access in the treatment of mental health conditions.
  • We are entrepreneurial, collaborative, and open-minded in how we approach our innovative work.
  • We are a new kind of pharmaceutical company that prioritizes public benefit over profit and is committed to sustainability, accountability, and transparency.

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. 

Clinical Research Regulatory Associate Executive Summary

MAPS PBC is seeking an enthusiastic, focused, and organized person to join our Clinical Operations Department. The Clinical Research Regulatory associate role will report to the Clinical Program Manager 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.     

Key Responsibilities

  • Source regulatory knowledge: be the point person for understanding, disseminating and advising on all federal and local regulations associated with Schedule 1 licenses for clinical trials.
  • Liaison for clinical sites: provide exceptional customer service with support and guidance for our clinical sites navigating through the regulatory process for applications and inspections.
  • Regulatory submissions and reporting: assist clinical sites with IRB, FDA, and IEC submissions by ensuring all essential documents are collected for study startups and throughout ongoing study conduct while maintaining audit readiness.

Minimum Requirements

What you bring to the role:

  • A bio-medical related scientific degree or relevant experience with a strong interest in clinical research. Minimum of bachelor’s degree preferred.
  • A minimum of 2 years CRA site management, monitoring, coordinating or other relevant experience is required.
  • Knowledge of U.S. regulations governing clinical trials and Good Clinical Practices
  • Cover letter required; incomplete applications may not be considered.

MAPS PBC is a distributed team that uses technology and periodic in-person gatherings to stay connected. We look for people who are comfortable with and skilled at remote work and collaboration.

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!

Job Features

Job Category

Clinical, Research

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