Clinical Research Coordinator I

About the Role

The Clinical Research Coordinator I will provide research, regulatory, and administrative support to the Principal Investigator and study team in the implementation and coordination of research protocols. The incumbent will assist with studies focused on evaluating the accessibility of medical devices, developing accessibility assessment tools, and investigating the preferences of individuals with disabilities when selecting and purchasing medical devices. Responsibilities include participant recruitment and enrollment, data collection and management, regulatory support, and coordination of day-to-day research activities.

Key Responsibilities

• Coordinate and support research activities in accordance with study protocols, institutional policies, and regulatory requirements.
• Maintain compliance with Good Clinical Practice (GCP), Institutional Review Board (IRB), and sponsor requirements.
• Assist with the preparation, submission, and maintenance of IRB applications, continuing reviews, amendments, and study reports.
• Support the development and implementation of surveys, discrete choice experiments, and other study instruments.
• Assist with testing and maintaining web-based research tools and accessible survey platforms.
• Conduct literature reviews and market research to support study activities and medical device selection.
• Assist with the implementation and evaluation of the MED-AUDIT accessibility assessment software.
• Develop study materials, training resources, and participant-facing communications as needed.
• Recruit, screen, and enroll research participants according to study eligibility criteria and protocol requirements.
• Maintain ongoing communication with study participants and coordinate study visits, follow-up activities, and data collection.
• Track participant enrollment, retention, and compensation.
• Collect, enter, verify, and maintain study data using electronic databases and research management systems.
• Organize and maintain study records, regulatory documentation, and research databases.
• Coordinate activities of student assistants and other research support personnel as assigned.
• Assist with data summaries, presentations, reports, manuscripts, and other dissemination activities.
• Manage study supplies, equipment, and research-related materials.
• Assist with purchasing, inventory management, and other administrative functions supporting research operations.
• Perform additional related duties and responsibilities as assigned.

Requirements & Tech Stack

• Bachelor's degree or an equivalent combination of education, training, and experience.
• Experience working with individuals with disabilities and knowledge of accessibility principles and practices.
• Experience leading or coordinating software, application, or technology development projects.
• Proficiency in Python, R, SAS, or similar programming languages for research design, data processing, and analysis.
• Strong organizational, communication, and project management skills.
• Ability to work independently and collaboratively within a team environment.
• Strong analytical and problem-solving skills.
• Excellent interpersonal, verbal, and written communication skills.
• Knowledge of clinical and human subjects research regulations and procedures.
• Attention to detail and commitment to data quality and accurate recordkeeping.
• Ability to maintain professionalism, confidentiality, and respect for participants' rights, privacy, and individual needs.
• Experience managing research databases and electronic data systems.
• Medical clearance and participation in applicable medical surveillance programs, if required.
• Contact with patients and/or human research subjects.
• Successful completion of all required institutional compliance, regulatory, and systems training.

Qualifications

• Master's degree preferred; doctoral degree (PhD or equivalent) highly desirable.
• Experience conducting human subjects research and managing IRB-regulated studies.
• Experience with laboratory or research supply procurement and inventory management.
• Familiarity with laboratory safety procedures, biosafety practices, and compliance documentation.
• Experience supervising, mentoring, or training student researchers or research staff.
• Demonstrated ability to work independently while managing multiple projects and competing deadlines.