Senior Research Coordinator - Pediatrics - CRA Neurology Research

Job Duties

• Screens, recruits, and enrolls patients/participants into complex clinical research studies in accordance with approved protocols.
• Conducts participant interviews and verifies eligibility based on comprehensive inclusion and exclusion criteria.
• Educates participants on study purpose, procedures, risks, and requirements and conducts the informed consent process in compliance with GCP and institutional policies.
• Exercises independent judgment in evaluating participant eligibility and protocol compliance.
• Supports study feasibility assessments through evaluation of patient populations, protocol requirements, staffing resources, and operational workflows.

Subject Visits

• Provides study-specific education to research participants within scope of practice.
• Reviews study protocols with participants and verifies informed consent documentation prior to study activities.
• Schedules participants for protocol-required tests and procedures, including laboratory assessments and study-specific evaluations.
• Dispenses investigational products in accordance with protocol requirements, institutional policies, and applicable regulatory standards while maintaining complete drug accountability records.
• Collections, processes, stores, and ships biological specimens in accordance with protocol requirements, laboratory manuals, and IATA guidelines.
• Maintains participant safety, rights, and welfare throughout study participation.
• Identifies, documents, and facilitates reporting of adverse events, serious adverse events, and protocol deviations in accordance with protocol requirements and regulatory timelines.

Data Collection & Entry

• Collects, documents, and records study-related data in collaboration with Principal Investigators, physicians, advanced practice providers, research nurses, and data managers.
• Obtains participant information through direct interviews, questionnaires, and medical record abstraction; enters data into case report forms and electronic data capture systems.
• Maintains accurate source documentation, study records, and essential study files to ensure compliance with regulatory requirements.
• Ensures the accuracy, completeness, and scientific integrity of study data through ongoing review and quality oversight.
• Aids with study monitoring visits, audits, and inspections as required.

Source Document Development & Review

• Prepares and maintains documentation required for initial and continuing regulatory approval of assigned research protocols.
• Oversees the development, organization, quality review, and maintenance of study source documents and regulatory files.
• Ensures study documentation meets sponsor, institutional, FDA, and GCP requirements.
• Participates in study start-up activities, including review of protocol requirements, operational workflows, and site readiness.
• Provides guidance to research staff regarding study documentation standards and protocol implementation.

Communication with Sponsors, Subjects, and Investigators

• Communicates independently with Principal Investigators, sponsors, contract research organizations (CROs), and study teams regarding study conduct, enrollment status, and operational challenges.
• Sets up and submits serious adverse event reports, protocol deviations, and follow-up documentation within required timelines.
• Facilitates study-related communication across participating sites, departments, and external partners.
• Coordinates study-related supplies, investigational products, equipment, and vendor activities as needed.
• Trains and mentors clinical research personnel on study operations, enrollment processes, protocol requirements, EMR workflows, regulatory requirements, and SOP compliance.
• Provides oversight and operational guidance to lower-level research personnel regarding study set-up, conduct, and research best practices.
• Adheres to FDA Good Clinical Practice (GCP) standards and all Baylor College of Medicine, Texas Children’s Hospital, and Clinical Research SOPs governing the conduct of clinical research.
• Work Experience:
• 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.