Clinical Research Coordinator 1 - Emergency Medicine

Job Summary

The Clinical Research Coordinator 1 will be responsible for day-to-day research operations across community-based, clinical, and data-driven projects; managing IRB submissions and regulatory documentation; assisting with participant recruitment and enrollment; organizing qualitative interviews, focus groups, and stakeholder engagement activities; tracking study timelines and deliverables; and maintaining high-quality study data. The coordinator may also help liaise with community health workers, public health agencies, healthcare providers, schools, and other partner organizations, making strong communication and relationship-building skills especially important.

Responsibilities

• Serve as a resource person or act as a consultant within area of clinical expertise.
• Maintain working knowledge of current protocols, and internal SOPs.
• Assist with or plan and implement the clinical study's goals and objectives; organize participant enrollment planning; conduct quality assurance activities, compile and analyze data.
• Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
• Be accountable for high standards of research practice and assist in the development of accountability in others.
• Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
• Participate in the coordination and conduct of complex research studies and ensure compliance with federal and institutional regulations.
• Prepare, submit, and assist Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• Provide Investigators with guidance regarding protocol requirements.
• Maintain regulatory documentation.
• Assist other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
• Prepare for and assist with audits, inspections, and monitoring visits from regulatory agencies or sponsors.
• Accountable for all tasks in complex studies.
• Performs various professional, organizational, and operational tasks under limited supervision.
• Acts as a resource on clinical research and related aspects of clinical study for other clinical research staff.
• Accountable for complex problem solving on assigned research studies and professional tasks.
• Assists with various professional, organizational, and operational tasks under direct supervision.
• Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
• Performs other related work as needed.

Minimum Qualifications

Education: Minimum requirements include a college or university degree in related field. Work Experience: Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Preferred Qualifications

Education: Master’s degree in public health, social work, epidemiology, health services research, or a related field.

Experience: Experience in clinical research, public health research, community-based research, or research administration. Experience with human subjects research, including informed consent, participant confidentiality, and IRB/regulatory processes. Experience supporting participant recruitment, scheduling, and study operations. Experience in emergency medicine, health services research, population health, or implementation science. Experience with quantitative research support, including survey administration, chart review, and basic data analysis. Experience with community-engaged research or community-based participatory research. Experience coordinating qualitative research activities, including interviews, focus groups, transcription, and coding workflows. Experience working with schools, public health departments, community health workers, or community-based organizations.

Technical Skills or Knowledge: Knowledge of medical terminology/environment. Knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements. Knowledge of machine learning and artificial intelligence methods for data analysis, prediction, and decision-support applications. Read and understand complex documents, such as clinical trials.

Preferred Competencies: Interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Interact compassionately with transplant patients and families. Strong attention to detail and data accuracy. Excellent interpersonal skills. Strong data management skills and attention to detail. Handle competing demands with diplomacy and enthusiasm. Prioritize multiple studies simultaneously. Absorb large amounts of information quickly. Adaptability to changing working situations and work assignments. Bilingual proficiency in English and Spanish.