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 for all assigned 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 Head of Safety and the Head of Clinical Operations.
Job Type: 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 ). The exact schedule may be arranged upon hire. Occasional weekend hours may be required with advance arrangement.
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics while 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) non-profit organization.
More information about the organization is available at https://mapspublicbenefit.com.
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, arrest or conviction record, 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. MAPS PBC strives to continually improve upon the supportive, equitable, and accessible work environment.
What You’ll Be Doing
- 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 , Chief Medical Officer and other bodies requiring regular updates
- Be a medical expert, in consultation with the other MDs in the Safety Department, 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
- 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 Safety Department in 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 Safety and Clinical Operations Department, MPBC staff and external groups including CRAs, Medical Monitors and Directors, other Department Heads, 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
What We Expect from You
- 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 and 1-2 years clinical experience after graduation.
- EU experience required.
- 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.
- 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 Chief Medical Officer and Head of Clinical Operations, 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 Regulatory submissions for INDs and NDA
- Review and support of participant enrollment confirmation documentation for clinical trials
- Review, communicate and process SAEs for clinical trials in coordination with the clinical teams according to SOPs and study plans
- 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
Exempt (i.e. not eligible for overtime)
Upon Request. Includes excellent benefits package.