Clinical Research Coordinator Associate

DESIRED QUALIFICATIONS:

• Bachelor’s degree in a health, behavioral, biological, or social science field preferred.

• Prior experience coordinating clinical or human-subjects research.

• Experience with participant recruitment and informed consent/assent, IRB submissions, REDCap or comparable data-capture systems, electronic medical records, and regulatory documentation strongly preferred.

• Familiarity with qualitative or mixed-methods research, including interviews and focus groups, is desirable.

• Proactive and self-directed, with demonstrated initiative, sound judgment, and the ability to anticipate needs, identify problems, and follow projects through to completion.

• Ability to manage multiple protocols and competing deadlines while maintaining accuracy, attention to detail, confidentiality, and regulatory compliance.

• Strong interpersonal skills and demonstrated ability to communicate sensitively with children, adolescents, young adults, and caregivers and collaborate effectively across clinical and research teams.

• Experience working with diverse patient populations and addressing barriers to research participation is desirable.

EDUCATION & EXPERIENCE (REQUIRED):

• 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 (REQUIRED):

• Strong interpersonal skills. Proficiency with Microsoft Office. Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use light/fine grasping. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, or lift, carry, push, and pull objects that weigh 40 pounds or more.

*

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.

WORKING CONDITIONS:

This is primarily an onsite position and may require work at approved Stanford Medicine Children's Health clinic or research locations. Occasional evening or weekend hours may be required based on participant and study needs.

Clinical Research Coordinator Associate - Celiac Disease and Inflammatory Bowel Disease

Position Summary

The Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition and the Stanford Medicine Children’s Health Center for Pediatric IBD and Celiac Diseaseare seeking a dynamic Clinical Research Coordinator Associate (CRCA). This role will work closely with Hilary Jericho, MD, MSCI, Endowed Medical Director for Celiac Disease; Senior Program Director Ashley Dunn, MPH; and other Center investigators and research staff to coordinate a growing portfolio of patient-centered and translational research designed to improve the health, quality of life, and everyday experiences of children and families living with celiac disease and IBD.

Under the leadership of Dr. Jericho, Stanford’s pediatric celiac disease program integrates medical care with celiac-specific nutrition, psychology, social work, nursing, education, and transition support. Its research extends beyond diagnosis and dietary management to examine psychosocial well-being, peer connection, school and college experiences, food access, treatment adherence, health equity, the microbiome, and emerging therapeutic approaches. The broader Center brings together clinicians, scientists, research staff, and community partners to translate discoveries into practical improvements in care.

Approximately 75% of the position will support Dr. Jericho’s celiac disease research portfolio. Current and emerging areas of research include peer mentorship, school experiences, gluten-free food access and food insecurity, psychosocial well-being, quality of life, transition to adulthood, microbiome science, and emerging therapeutic approaches. The remaining 25% will support Center-wide IBD and celiac disease studies, including the Center’s biorepository and other shared research priorities. Specific study assignments may evolve as projects open, enroll, and close.

The CRCA will coordinate moderately complex aspects of multiple studies from start-up through close-out. Responsibilities will include identifying and recruiting eligible participants; obtaining informed consent, parental permission, and assent; coordinating study visits, surveys, interviews, focus groups, and longitudinal follow-up; collecting and managing clinical, patient-reported, qualitative, and laboratory data; supporting biospecimen workflows; maintaining REDCap databases and regulatory documentation; preparing IRB submissions; and collaborating with clinical teams, laboratories, sponsors, monitors, and external research partners.

The ideal candidate will demonstrate exceptional organizational, interpersonal, and communication skills, with a strong capacity for professional discretion and handling sensitive clinical and research information. They should be proactive, dependable, and self-directed, with the initiative to anticipate study needs, identify and address operational challenges, and follow projects through to completion. The candidate must be able to manage multiple protocols and competing deadlines while maintaining accuracy, regulatory compliance, and attention to detail. They should also be comfortable communicating sensitively with children, adolescents, young adults, and caregivers and collaborating effectively with diverse clinical, research, and laboratory teams.

Joining our team offers a unique opportunity to contribute to leading-edge research and innovative patient care initiatives. The CRCA will work with nationally recognized faculty, participate in multidisciplinary and community-engaged research, and play a meaningful role in translating the priorities and experiences of patients and families into evidence, interventions, and resources. If you are organized, proactive, collaborative, and passionate about improving the the lives of children and families affected by IBD and celiac disease, we encourage you to apply.

The Stanford Medicine Children’s Health Center for IBD and Celiac Disease comprises pediatric gastroenterologists, scientists, psychologists, dietitians, nurses, social workers, research professionals, and other healthcare specialists focused on delivering the highest-quality care for children. Our Center is a dynamic and stimulating place to work, and because we are committed to continued growth and excellence, our staff have particularly challenging and rewarding roles. The goal of our Center is to advance the diagnosis, treatment, and lifelong management of IBD and celiac disease through integrated clinical care, innovative research, education, and community engagement.

Guided by the best available scientific evidence, we seek to improve long-term health and quality of life while engaging patients and families as active partners in care and research. The Center serves children and families from throughout the Bay Area, Northern and Central California, and surrounding states. Our outpatient locations include Palo Alto, San Francisco, Walnut Creek, San Jose, and additional satellite clinics.

Duties Include

• Coordinate assigned studies from start-up through close-out and maintain timelines, regulatory files, tracking tools, and study-status reports.

• Identify and screen potential participants; obtain informed consent, parental permission, and assent according to approved protocols; and support recruitment and retention strategies.

• Schedule and conduct research visits and coordinate surveys, interviews, focus groups, follow-up activities, and participant communications.

• Collect and manage clinical, patient-reported, qualitative, and laboratory data in Epic, REDCap, sponsor systems, and other approved platforms.

• Coordinate specimen collection, labeling, processing handoffs, transport, storage documentation, and inventory activities for celiac studies and the Center's biorepository.

• Prepare and maintain IRB submissions, amendments, continuing reviews, reportable-event documentation, consent forms, delegation logs, and other essential study records.

• Review source documentation and case report forms for completeness and accuracy, resolve data queries, and maintain audit-ready study files.

• Communicate regularly with principal investigators, participants and families, clinical teams, laboratories, research administration, sponsors, monitors, and collaborating sites.

• Assist with study budgets, participant payments, monitoring visits, audits, abstracts, presentations, manuscripts, progress reports, and dissemination activities, as assigned.

Provide cross-coverage for other Center research studies and perform additional duties as assigned.

Responsibilities

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.

Qualifications

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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.