Part-Time Clinical Research Coordinator (Nutrition / Medical Device)

About Us:

Spoonified is a behavioral health technology company building AI-powered smart utensils designed to physically intervene and combat mindless eating. As we prepare for our next stage of growth, we are launching an on-site clinical research trial to test the efficacy and user experience of our hardware in real-world eating scenarios.

The Opportunity:

We are seeking a highly organized and autonomous Part-Time Clinical Research Coordinator to manage our upcoming clinical trials at our Richardson facility. You will be the operational engine behind this study, taking it from the initial design phase all the way through to final data compilation. This is a unique opportunity to lead clinical research for a first-of-its-kind digital health and hardware product.

Core Responsibilities:

Study Design & Setup:

Collaborate with the founder to draft the study protocol, establish data collection methods, and ensure all processes meet ethical and clinical standards.

Participant Recruitment:

Develop and execute a strategy to source, screen, and schedule qualified local participants for the on-site trial.

Trial Execution:

Conduct the on-site testing sessions in Richardson, guiding participants through the protocol while ensuring their comfort and compliance.

Data Management:

Meticulously collect, clean, and compile the trial data (quantitative device data and qualitative user feedback) into a comprehensive final report. Manage and coordinate clinical trial activities related to nutrition and medical device studies, ensuring adherence to study protocols and regulatory requirements.

Who You Are:

Experienced Researcher:

You have proven experience working as a Clinical Research Coordinator or in a similar capacity, ideally within the nutrition, behavioral health, or medical device sectors.

Process-Driven:

You have a deep understanding of clinical trial protocols, participant consent procedures, and rigorous data management.

Exceptional Communicator:

You possess a strong bedside manner and can make participants feel comfortable while providing clear, unbiased instructions during trials.

Self-Starter:

You thrive in an entrepreneurial environment and can independently manage the logistics of recruiting and scheduling without needing daily micromanagement. Ensure compliance with HIPAA privacy standards and CDISC data standards throughout all trial activities

Requirements:

Prior experience executing clinical studies involving human subjects. Ability to commute to our workspace in Richardson, TX, to conduct in-person trials. Part-time availability (exact hours to be determined based on the final study design and participant scheduling). Review and verify study documentation, including consent forms, case report forms, and regulatory submissions for accuracy and completeness. Conduct statistical analysis using software to interpret trial results and prepare reports for internal consumption. Background in nursing or clinical laboratory work is advantageous; experience with clinical development phases is preferred Excellent analysis skills with attention to detail to ensure accurate documentation review and compliance management

Pay:

$20.00 - $25.00 per hour Ability to

Commute:

Richardson, TX 75081 (Required)

Work Location:

Hybrid remote in Richardson, TX 75081