The Food is Medicine Institute is a new collaborative effort at Tufts, bringing together faculty and students from the Friedman School, other university units, and national partners to advance research, training, patient care, and community engagement around food is medicine (FIM). FIM 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.

Information on FIM at Tufts is located at the following website https://tuftsfoodismedicine.org/. This first-of-its-kind Institute will lead the nation in collaborative, high impact efforts to transform healthcare by integrating high-value food-based nutritional interventions and related programs as therapeutic and preventive interventions. The Institute will serve as a catalyst to drive change, improve health, reduce health disparities, and create a more equitable and resilient healthcare system that recognizes the power of food as medicine.

This is a grant funded and 4 year limited term position.

The Director of Clinical Trials at the Food is Medicine Institute will be responsible for overseeing and managing all aspects of the Institute’s clinical trial activities. This individual will be in charge of organizing and directing design and implementation of clinical trials at FIMI and across our national network. The individual will ensure the successful planning, execution, and completion of clinical trials in accordance with applicable regulations and guidelines. The ideal candidate will have a strong background in clinical research, exceptional leadership skills, and a passion for advancing knowledge around food is medicine in order to improve health. Activities associated with this leadership position include but are not limited to strategic planning; trial design and protocol development; coordination of the submission of IRB and related regulatory documents, and ensuring compliance with local, federal, and sponsor/funding agency clinical trials policies; education of staff regarding research policies; coordination with Research Administration to ensure budgets are developed appropriately and development and maintenance of positive sponsor relationships; operational oversight; vendor management; risk assessment and mitigation; quality assurance; collaboration and stakeholder management; and data analysis and reporting.

Principal Duties and Essential Functions

• Serves as an integral member of FIMI. Supports the Director of the Institute in fulfilling the center’s mission and ensures the quality of clinical research resources and integrity of services.
• Develops and implements a comprehensive clinical trial strategy aligned with the Institute’s goals and objectives.
• Collaborates with cross-functional teams to design and develop clinical trial protocols that address research objectives, regulatory requirements, and ethical considerations.
• Ensures compliance with all relevant regulations, guidelines, and ethical standards governing clinical trials, including obtaining necessary approvals from regulatory authorities and ethics committees.
• Is responsible for accurate and timely submission of IRB documents, data submission to the Clinical Trial Management System (CTMS) and data collection requirements for study sponsors.
• Oversees the allocation and management of financial and personnel resources for clinical trials, ensuring efficient and effective use of available resources.
• Provides guidance and direction to the clinical trial teams to ensure smooth and successful trial execution.
• Is responsible for closely monitoring pre-screening and enrollment efforts, outside of the management of the clinical research teams.
• Collaborates with external vendors, such as Contract Research Organizations (CROs), clinical laboratories, and imaging facilities, to ensure their effective contribution to the clinical trial process.
• Identifies potential risks and challenges associated with clinical trials and develops appropriate strategies to mitigate them.
• Implements quality control measures to ensure data integrity and adherence to standard operating procedures (SOPs) throughout the trial lifecycle.
• Fosters effective relationships with internal and external stakeholders, including principal investigators, study sites, regulatory authorities, and patient advocacy groups.
• Maintains collaborative, team relationships with peers and colleagues to effectively contribute to the working groups’ achievement of goals, and to help foster a positive work environment.
• Oversees the analysis and interpretation of trial data, preparation of study reports, and dissemination of findings to relevant stakeholders.
• Ensures completion of each study on time and on budget and supervises the curating and logging of all study monitor and audit follow-up reports to ensure a high-level view of significant findings and trends and identifies areas of improvement and development of new methodologies to meet milestones.
• Works collaboratively with Research Administration to facilitate budgetary discussions related to funding, staffing, and financial projections. Participates in financial discussions related to specific clinical trials with Research Administration and Physician Lead/Designee as needed.
• Promotes a responsive and customer-oriented organizational structure.
• Stays abreast of industry trends, emerging technologies, and best practices in clinical trial management, and recommends process improvements to enhance efficiency and quality.
• Performs other similar and related duties as required or directed.

Basic Requirements:

• Knowledge and skills as typically acquired through completion of Master’s degree in science, business administration, public health, and healthcare administration, or nursing 8+ years managing clinical research trials, preferably in a leadership role
• Extensive experience in healthcare research and related compliance, auditing, conducting investigations, monitoring standards, or related experience
• Substantial knowledge of Federal, State, and institutional laws and regulations which govern research financial compliance; substantial knowledge of Medicare National Coverage Determination that regulates research financial compliance for clinical trials
• Substantial knowledge of clinical research protocols, principles, and procedures
• Substantial knowledge of clinical trials budget development and negotiation, financial auditing, and other clinical research methods such as screening, interviewing, reviewing medical records, case report forms, etc.
• Excellent leadership and managerial skills, with the ability to inspire and motivate cross-functional teams as well as the ability to direct activities both individually and within a project team
• Proficient computer skills
• Must possess strong planning, problem-solving, analytical, organizational, project management, interpersonal and oral/written communication skills
• Requires meticulous attention to detail and the ability to manage multiple priorities
• Ability to analyze and interpret data
• Strong knowledge of Good Clinical Practice (GCP) guidelines, international regulations, and ethical considerations governing clinical trials
• Proven track record of successfully managing multiple clinical trials simultaneously, from study start-up to close-out
• Exceptional organizational and project management abilities, with a keen attention to detail
• Strong analytical and problem-solving skills, with the ability to make sound decisions in complex situations
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders
• Proficiency in relevant software and data management systems used in clinical trial operations

Preferred Qualifications:

• Experience with IND filings is highly desirable