The Reagan-Udall Foundation for the FDA (the FDA Foundation) is a non-profit organization that works to support the mission of the FDA by advancing regulatory science and research. The Foundation establishes public-private partnerships between FDA and external stakeholders to facilitate innovation in science and health. Learn more at www.reaganudall.org.

Job description:

The FDA Foundation’s research portfolio includes large scale collaborative observational and/or clinical trials, along with studies designed to develop and meet regulatory requirements for post-market surveillance of medical products. The Program Coordinator will provide coordination of research partnerships in epidemiology, clinical trials, and/or biomedical and behavioral research. The Coordinator will support the administration of policies and procedures governing the development and/or execution of these projects. The Coordinator will work with leading experts from government agencies (including NIH and FDA), industry, non-­‐ profit organizations, and academia to design and monitor the progress of medical product safety surveillance projects.

The Coordinator will coordinate a team to ensure that individual research projects in the portfolio are conducted in a timely and effective manner, and within budgetary constraints. The Coordinator will report to the Associate Director of Research. Minimal travel may be required for this position, but it is currently remote due to the COVID-19 pandemic.

Job qualifications:

The Coordinator should be intellectually flexible and comfortable working in an environment without detailed instructions. S/he should be able to see a process emerge and articulate that process to others. The Coordinator should be detail-­oriented, proactive, organized, have excellent writing and critical thinking skills, and be adept at multitasking.

The Coordinator should have a demonstrated ability to:

  • Coordinate a diverse portfolio of research projects, including:
    • Monitoring progress towards project milestones
    • Recommending and implementing modifications to effectively meet project milestone;
    • Ensuring that studies are conducted in accordance with applicable policies and procedures.
  • Facilitate internal and external project team meetings, tracking action items, and following up to ensure action items are being completed.

Preferred characteristics:

  • Two-three (2-3) years of combined research assistant and/or project coordinator experience, preferably in a scientific field.
  • Experience working in a healthcare setting or with healthcare data (clinical/epidemiological research background preferred).
  • Familiarity with issues related to research administration, including scientific journal submission process, IRB, data privacy and security, etc.
  • A graduate degree in a relevant field.

Salary: $70,000 - $85,000

About us: The Reagan-Udall Foundation for the FDA (the FDA Foundation) is a non-profit organization that works to support the mission of the FDA by advancing regulatory science and research. The Foundation establishes public-private partnerships between FDA and external stakeholders to facilitate innovation in science and health. Learn more at www.reaganudall.org.

Benefits: The FDA Foundation provides a comprehensive benefits plan to all full-time employees, including medical, dental, and vision (100% of employee premiums), short-term disability, long-term disability, life insurance, 401K retirement plan (with defined employer contribution regardless of employee contribution), workers’ compensation insurance, flexible savings accounts, and public transportation benefits.

To apply: Email your cover letter, resume, two references and your salary requirements to careers@reaganudall.org

Key words: Program coordination; research administration; public-­‐private partnership; pharmacoepidemiology; real-world data; post-market safety.