About this role
- 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.