The Childhood Research Obesity Prevention (CROP) research program under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) within Stanford University is seeking a Clinical Research Coordinator Associate based in New York City to perform duties related to the coordination of one clinical study and work under close direction of the principal investigator and project manager. These duties include developing study protocols, data collection tools, recruitment strategies; and screening, enrollment, randomization, and data collection for various research studies to promote food security, nutrition, and reduction of obesity and related chronic diseases starting early in life.
The CROP research program’s goal is to advance child health equity. To achieve this goal, the program seeks to translate clinical, community, and epidemiologic research findings into innovative population-level interventions during pregnancy, infancy, and early childhood to prevent and treat childhood obesity and chronic diseases particularly among health disparity populations. The culture of the program is one that values growth, teamwork, and inclusion. Current research projects are funded by NIH, PCORI, and Foundations amounting to over $20M total costs between 2024-2030 in addition to endowed program funding. These include the Food FARMacia randomized trial of an infant food security intervention; the LINC mixed methods study of social risk factors, navigation, and neighborhoods; and the PCORI-funded CHIME (Comparing Health Interventions for Maternal Equity) program. The CHIME program focused on maternal- infant health equity through a comparative effectiveness research study, broader partnership network, partner learning network, and research mentorship program.
The CROP Clinical Research Coordinator will have experience in conducting participant enrollment and data collection, maintaining clinical data in a research setting, and adhering to research protocols for the CHIME study. We are looking for someone who can collaborate with team members in New York City, other researchers, and external partners. The ability to manage multiple tasks and timelines, take initiative and complete appropriate tasks independently, and has proficiency in Spanish verbal communication at a fluent or native level to assist with communication with non-English speakers.
The Department of Pediatrics is a dynamic, stimulating place to work and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.
Duties include:
- Serve as a contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
- Determine eligibility of and enroll study participants according to protocol.
- Assist in developing recruitment and retention strategies.
- Coordinate collection of study specimens and processing.
- Collect and manage patient and laboratory data for clinical research projects for participants based in New York City. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed.
- Assemble study materials, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors.
- Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
* - Other duties may also be assigned
Core Duties:
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
- Coordinate collection of study specimens and processing.
- Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
- Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
- Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- Participate in monitor visits and regulatory audits.
Minimum Education and Experience
Two-year college degree and two years related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills and Abilities:
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
[REMOVE STATEMENT BEFORE POSTING - KEEP LANGUAGE BELOW, IF APPLICABLE. REMOVE IF NOT APPLICABLE]
Drivers License Requirements
Must possess and maintain a valid California non-commercial Class C Driver's License.
Ability to drive day or night.
When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.