Senior Research Coordinator - Pediatrics - CRA Neurology Research

Senior Research Coordinator - Pediatrics - CRA

The Senior Research Coordinator independently coordinates and manages complex clinical research studies in accordance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) guidelines. The position is responsible for the day-to-day operational management of clinical trials, including participant recruitment, study conduct, regulatory compliance, data quality, sponsor interactions, and study closeout activities for the division of Pediatric Neurology. The Senior Research Coordinator exercises substantial professional judgment and operates with minimal supervision while supporting investigators, study teams, and departmental research initiatives. Incumbent should be able to work in a fast-paced environment, comfortable working in a team environment, and leading the various stages of complex clinical research studies (feasibility, startup, enrollment, closeout). A successful candidate will have excellent organization skills, able to multitask, and strong verbal, written, and interpersonal skills. Extensive knowledge of FDA regulations, OHRP requirements, ICH-GCP guidelines, and human subject protections required. Provides independent clinical and administrative management of multiple complex therapeutic/interventional drug clinical research studies. Position requires leading rapid study start-up, high participant volumes, and intricate protocol requirements. Participates in study qualification and feasibility assessments and provides operational recommendations to Principal Investigators and Research Managers. Serves as a resource and mentor to research personnel while ensuring compliance with protocol requirements, regulatory standards, and institutional policies.

Job Duties

• Subject Visits 30%
• Screening & Enrollment 20%
• Data Collection & Entry 20%
• Additional Duties Source Document Development & Review 15%
• Communication with Sponsors, Subjects, and Investigators 15%

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications and Skills

• Bachelor's degree in scientific, healthcare, or public health related fields.
• Therapeutic clinical research study experience
• Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC).

Work Authorization Requirement: This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer. Requisition ID: 25979

Baylor College of Medicine