Research Assistant I – Non-Lab

## Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise. We are dedicated to creating a diverse and welcoming environment where everyone can thrive. **Why join Harvard Medical School?** Harvard Medical School's mission is to nurture a diverse, inclusive community dedicated to alleviating suffering and improving health and well-being for all through excellence in teaching and learning, discovery and scholarship, and service and leadership. You’ll be at the heart of biomedical discovery, education, and innovation, working alongside world-renowned faculty and a community dedicated to improving human health. This is more than a job - it’s an opportunity to shape the future of medicine. **About the Harvard Program in Therapeutic Science:** The Harvard-MIT Center for Regulatory Science advances research and education in regulatory science. The Center serves the broad community of biomedical research scientists and physicians in academia, industry, and regulatory agencies who seek to improve the development and evaluation of medical products. HMCRS members study the medical and economic impact of industry activities and regulatory policies, seeking more effective ways to develop and use innovative medical products. The Center collaborates with the US Food and Drug Administration on a fellowship program designed to prepare PhD and MD PhD trainees for academic, industry, and government positions at the intersection between science and regulatory policy. HMCRS hosts regular events that convene diverse stakeholders in regulatory science through annual symposia, topic-focused workshops, and working groups. ## Job Description The Harvard–MIT Center for Regulatory Science—a partnership established by Harvard, MIT, and the U.S. Food and Drug Administration—is seeking a recent college graduate for a full-time Research Assistant I (Non-Lab) position in regulatory science. Under the direction of the Center’s investigators, the Research Assistant performs a variety of non-laboratory research and clerical tasks determined by the field and scope of the particular research study. Working as part of an interdisciplinary team, the Research Assistant supports research initiatives that advance regulatory science and biomedical innovation, contributing to projects that inform the development, evaluation, and oversight of diagnostics, therapeutics, biologics, and emerging medical technologies. The individual in this role collaborates closely with investigators and partners across academia, industry, and government, and gains hands-on experience at the intersection of biomedical research, medicine, public health, and regulatory policy. Tasks will be performed under the supervision of the CRS Director. **Responsibilities include:** - Extracts and curates data from FDA regulatory documents and related sources, following established protocols and acquiring information through structured review, database queries, library research, and other research methods. - Records and codes data according to project requirements and established protocols, maintaining well-documented and reproducible datasets. - Conducts statistical analyses and processes, organizes, and summarizes data using a variety of scientific, spreadsheet, and statistical software applications. - As part of a team or with direction, may assist in the design of studies, experiments, and analyses. - Makes periodic reports of project status to the supervisor and other research team personnel. - Performs clerical duties incidental to research tasks and may assist with planning research meetings and other types of events. **Working Conditions:** - Candidate will work in a computational lab environment with other researchers collaborating on data analysis and publication. **Physical Requirements:** - Candidate will work on a laptop or othe…