Clinical Trials Director, Food Is Medicine Institute

The Food is Medicine Institute at Tufts University leads the nation in collaborative, high-impact efforts to advance research and evidence generation, training of leaders, patient care, community engagement, and policy around Food is Medicine. Food Is Medicine is a set of food-based nutrition programs and interventions integrated into the health care system to advance specific health needs and health equity in different populations.

The Institute aims to help transform healthcare by integrating high-value, food-based nutritional interventions and related programs as both therapeutic and preventive measures. The Institute acts as a catalyst to drive change, enhance health, reduce health disparities, and build a more equitable and resilient healthcare system that recognizes the power of nourishing food. More information can be found at: https://tuftsfoodismedicine.org.

This is a grant-funded, 3-year limited-term position, with potential renewal based on performance, Institute needs and priorities, and funding.

The Clinical Trials Director at the Food is Medicine Institute will oversee and manage all aspects of the Institute's clinical research activities. This individual will collaborate with the Institute Director, Managing Director, and faculty to:

• Strategize and design clinical research studies, including partnerships with external collaborators across a national network
• Develop clinical research proposals for submission to funding agencies
• Create protocols for database management, regulatory/IRB compliance, human subject protection, and study recruitment
• Ensure successful planning, execution, and completion of clinical research studies in accordance with applicable regulations
• Guide and mentor faculty, trainees, and study staff on protocol development, regulatory processes, and recruitment strategies

Additional responsibilities include strategic planning, oversight of IRB submissions and regulatory documentation, compliance with local, federal, and sponsor policies, management of single and multicenter trials, staff education on research policies, budget development and coordination with Research Administration, sponsor relationship management, operational oversight, vendor management, risk mitigation, quality assurance, stakeholder engagement, and data analysis and reporting.

The ideal candidate will have a strong background in clinical research implementation with experience and interest in clinical trials, qualitative studies, and survey research; exceptional leadership skills; and a passion for advancing knowledge around food is medicine to improve health.

Basic Requirements:

• Knowledge and skills as typically acquired through completion of a master's degree in science, business administration, public health, healthcare administration, or nursing
• 5+ years managing varied clinical research programs, preferably in a leadership role
• Extensive knowledge of clinical research protocols, principles, procedures, and regulatory requirements
• Strong expertise in clinical trials budget development, negotiation, and financial auditing
• Deep understanding of Good Clinical Practice (GCP) guidelines, international regulations, and ethical considerations
• Proven track record of managing multiple clinical trials from start-up to close-out, Experience designing and conducting qualitative research studies
• Advanced planning, organizational, and project management abilities
• Strong analytical and problem-solving skills
• Excellent interpersonal and communication skills
• Proficiency in clinical trial software and data management systems
• Ability to manage multiple priorities with meticulous attention to detail

Preferred Qualifications:

• Experience collaborating with external partners across a national network
• Demonstrated ability to mentor faculty, trainees, and study staff
• Familiarity with sponsor relationship management and vendor oversight
• Experience with risk assessment, quality assurance, and stakeholder engagement
• Ability to analyze and interpret complex data for reporting and decision-making
• Proficiency in survey research methods, including data collection and analysis using platforms such as Qualtrics or REDCap