Job Description

Summary

This position will coordinate complex, multi-site and international clinical research studies. The position will be responsible for participant management, regulatory compliance, quality assurance, data management oversight, site coordination, and training of study personnel.

TN visa holders are encouraged to apply.

Job Duties

• Clinical Research Coordination and Participant Management: Coordinate and conduct participant screening, enrollment, follow-up, and monitoring activities for research studies, including those involving investigational drugs, devices, and procedures. Serve as the primary point of contact for multi-country research sites regarding participant recruitment, screening, enrollment, retention, and study conduct. Ensure study activities are completed in accordance with approved protocols, sponsor requirements, and institutional policies.
• Regulatory Compliance and Study Oversight: Manage regulatory activities throughout the study lifecycle, including protocol submissions, amendments, continuing reviews, and reporting requirements. Ensure compliance with Baylor, sponsor, and applicable international regulatory requirements across all participating study sites. Maintain regulatory documentation and support audit and inspection readiness.
• Site Coordination and Stakeholder Communication: Serve as the primary liaison between investigators, study teams, sponsors, contract research organizations, and international research partners. Respond to study-related inquiries and facilitate communication among internal and external stakeholders. Coordinate study implementation and ongoing operational activities across multiple research sites.
• Training, Mentorship, and Program Support: Serve as the primary trainer and mentor for research coordinators and study personnel at collaborating domestic and international sites. Provide guidance on protocol implementation, regulatory requirements, study procedures, and data collection processes. Contribute to process improvement initiatives and best practices for study coordination and compliance.
• Data Management and Quality Assurance: Oversee study data management activities, including data review, query resolution, and data quality monitoring. Review case report forms and study documentation to ensure completeness, accuracy, and compliance with protocol requirements. Coordinate quality assurance activities and monitor adherence to regulatory and institutional standards across participating sites.
• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Bachelor's degree in a related field.
• Prior clinical research experience is required.
• Bilingual in Spanish is preferred due to the patient population served.

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.