The Metabolic Research Specialist will play a lead role in study intervention to assess individualized dietary requirements. Under the general supervision of the Research Project Managers and in collaboration with the Clinical Site Coordinators, the position independently manages the metabolic food laboratory kitchen as it relates to NPH. As a key member of the UNC-CC clinical research team, the position directs, coordinates and supervises Dietetic Technicians and the daily operations of the metabolic food laboratory to meet the production timeline based on the recruitment schedule. It works across functional areas including the metabolic food laboratory and clinical suite.
It also works closely with the leadership team to develop and adapt procedures and policies that ensure research needs are met, and controlled diets are delivered. The position is dedicated 100% to NPH. A key resource needed to conduct this trial is a metabolic food laboratory to produce the nutrient controlled meals to the precision and accuracy standards established in the NPH Diet Intervention Manual of Procedures. Three distinct diets are precisely prepared and provided to participants to consume at home, each for two (2) weeks at a time.
Strict diet production procedures must be adhered to to ensure consistent production of the study diets across all ten (10) diet production facilities across the six (6) Clinical Centers. Foods must be procured to meet exact brand, nutrient and ingredient specifications. Each food must be weighed to 1/10th of a gram and quality control methods must be used to check each recipe and ensure all foods are included in provisions to participants. The position will establish close relationships with participants in working with them on diet instruction and adherence throughout the total of six (6) weeks consuming these diets.
The integrity of the study data relies heavily on this position to carry out the diet intervention procedures as per protocol and manual of procedures. It is critical for ensuring that food safety and sanitation guidelines are adhered to throughout the procurement and production process.
This position works closely with the study coordinator on forecasting visits and metabolic food laboratory needs so that clinic demands and metabolic food laboratory demands are balanced to meet planned milestones. The position will utilize the ProNutra software, designed specifically for metabolic food labs and used to generate the meal production sheets and labels for each participant for each day of diet.
The position also oversees and meets with research participants to conduct energy calculations per protocol and adjust master menus with unit foods to achieve energy to the nearest 100kcals of the participants needs. The position meets with participants at meal pick-ups (3-4 days’ worth of food at a time) at which time any weight changes and energy adjustments are assessed as per protocol.
At meal pick-ups, participants are evaluated for adverse events, which are documented and evaluated, alongside the research nurse for relatability to the research protocol. Food pick-up also includes a review of the participants daily food log and provision of diet adherence counseling to improve any adherence issues and improve study data. The position collects data at each food pick-up and enters into REDCap, a browser-based, metadata-driven electronic data capture software and workflow methodology for designing clinical and translational research databases. The position is also responsible for evaluation and resolution of data queries as presented by the Data Coordinating Center.
Minimum Education and Experience Requirements
Bachelor’s degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.
Required Qualifications, Competencies, and Experience
* Possess an understanding of food resource management strategies, food safety, food preparation, food composition, and basic cooking skills.
* A proven track record in working well both independently and as part of a team. Independent problem-solving skills are essential.
* Must demonstrate exceptional written and verbal communication skills. Excellent customer service and communication skills are required in this position.
* The position requires strong organizational skills to manage multiple workflows (staffing, participant scheduling, and meal production).
* Ability to work a flexible schedule as needed, often including early morning hours, with the possibility of occasional weekend and/or evening hours. Flexible scheduling is shared across team members.
Preferred Qualifications, Competencies, and Experience
* Registered Dietitian or eligible to sit for Commission on Dietetic Registration exam by hire date.
* Proficient in data management software such as ProNutra and REDCap.
* Prior management and/or supervisory experience.
* Knowledge of clinical research and regulatory standards that apply to research and human clinical trials. Possess an understanding of the importance of following protocol and reporting any formulation changes or errors immediately as it relates to study integrity.
* ServSafe certification
* Bilingual (Spanish) candidates are strongly encouraged to apply.
Special Physical/Mental Requirements
Must be able to perform the following functions with or without reasonable accommodation:
* Must be comfortable using industrial kitchen appliances and tools.
* Ability to move or lift objects weighing up to 50 lbs.
* Ability to stand for extended periods of time; bend, stoop, and pull to complete work.
* Must have strong hand-eye coordination and work with detailed precision while maintaining quality assurance expectations.
* Visual attention, mental concentration, and manipulative skills are critical when ordering materials, calculating units of measure, and recording data.
