Medical Monitor

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MAPS Public Benefit Corporation (MPBC) 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, MPBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at mapspublicbenefit.com.

MPBC 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.

MPBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MPBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Call for Candidates

Furthering MAPS Public Benefit Corporation’s clinical development program by assisting in the design, conduct, and safety review of clinical trials.The Medical Monitor is responsible for reviewing safety data and ensuring the safety of study participants in clinical studies in a team setting while working throughout the product’s lifecycle. Helping to ensure that products are utilized effectively, serving as a scientific peer and providing resources within the medical community and are scientific experts to internal colleagues as needed. The Medical Monitor 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, and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s). The focus of the Medical Monitor role is supporting safety review by the Safety Review Committee for all clinical trials, from responding to site questions, reviewing of participant enrollment packets, safety data line listing review, safety information review in documents, safety monitoring at local sites and engaging Key Opinion Leaders and Clinical Investigators under the direction of the Medical Director and the guidance of the Chief Medical Officer and the Director of Clinical Operations. Interested and qualified candidates are encouraged to apply online at: tinyurl.com/applyMPBC

 

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet meetings. Certain home office expenses may be reimbursed. A work computer will be provided. Priority is placed on applicants based in the pacific time zone and Bay Area who can work a percentage of time in office in Oakland. The MAPS PBC headquarters office is located in Santa Cruz, CA. Travel will be required.

 

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). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.

 

Minimum requirements

  • Clinical degree (MD, DO, NP, PA, PharmD) with strong leadership skills, preferably with 2-5 years direct experience in the pharmaceutical industry or clinical research, preferably in a medical monitoring role.
  • US and EU experience preferred.
  • Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs.
  • Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders.
  • Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing.
  • Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities.

General Responsibilities

  • Attends, creates presentations and provides training in Study Conduct/ GCP/ICH/FDA/SOP at Initiation/investigators meetings, clinical team meetings as appropriate
  • Provide study updates to Directors and other bodies requiring regular updates
  • Be a medical expert, in consultation with the Medical Director, for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial
  • Attendance at video conferences and face-to-face meetings with study teams, ensuring alignment across policies/procedures and ensure that data generated meet monitoring and compliance with FDA, ICH guidelines and GCP
  • Light travel as project needs require

Documents

  • Contribute to and review protocol and protocol related documents (ICF, CRFs, Source Records, Study Reference Manuals, Monitoring Plans, as appropriate), ensuring proper timelines are kept in creation and implementation
  • Takes active part in study design internal discussion and site discussion
  • Lead medical aspects of medical monitoring under the guidance of the Medical Director, Chief Medical Officer, and Clinical Operations and Regulatory Departments, providing medical input into safety reports including, SAE narratives and analysis of similar events, and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of Safety and Efficacy, Clinical Study Reports, Annual Reports, regulatory submissions and preparation of labels
  • Participates in the preparation of FDA submissions for INDs and NDA
  • Review and support of participant enrollment confirmation documentation for clinical trials under guidance of the Medical Director and Chief Medical Officer
  • Review, communicate and process SAEs for clinical trials in coordination with the clinical teams according to SOPs and study plans

Specific Responsibilities

  • Assist in medical review, assessment and interpretation of clinical and safety data to ensure proper clinical trial site oversight with an eye toward safety
  • Ensure that the data are correct and presented with the appropriate medical interpretation including review of medical terms and coding
  • Supporting the Medical Director who is responsible for the development and implementation of standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting and assuring compliance with global and local regulatory requirements.
  • Coordinate with researchers globally to conduct clinical trials, providing support in their efforts and coordinating safety communications between key players
  • Maintain effective communication and facilitate the exchange of information within the Clinical Department, MPBC staff and external groups including CRAs, Medical Director and Chief Medical Officer, Department Heads, CRA’s, Site Staff, Data Management, Regulatory, Finance, Logistics, Adherence Raters and other collaborators
  • Mentor CTLs, CRAs, CSAs and Interns in study safety and compliance
  • Provide input and assist in training in the creation and review of study training material or other formal training at site and at the study team level, especially as it pertains to safety
  • Liaise with doctors/consultants/investigators on conducting the trial
  • Review monitoring trip reports, on an as needed basis, of status of each of the studies and make any necessary recommendations for contingency planning where safety is concerned
  • Ensure safety review is in compliance with appropriate SOPs and Monitoring Plans
  • Review the trending of monitoring findings (deviations/data listings/communications) to ensure resolution of safety and medical issues including risk mitigation ensuring proper retraining of clinical and site staff as appropriate
  • Ensure the quality of study data by reviewing data listings, ensuring AEs, AESI, SAEs, concomitant medications, and inter current illnesses are reviewed for consistency with medical diagnosis and action taken and reported in accordance with study protocols, providing feedback and ensuring proper retraining of clinical and site staff as appropriate
  • Ensure timely reporting, escalation and review of important AEs and SAEs
  • Track study progress using tracking tools, ensuring timely and quality updates

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
  • Ability to make public presentations and represent MAPS/MPBC at conferences

Compensation

Salary range disclosed upon request. 

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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.