Summary

The Department of Medicine, Section of Gastroenterology & Hepatology at Baylor College of Medicine is looking to recruit an enthusiastic and reliable Senior Clinical Research Associate for day to day operations of research projects for Drs. Kramer and Kanwal. The candidate will direct daily project activities, design and maintain study databases, and oversee participant recruitment for various research projects. The candidate will also manage regulatory and institutional compliance tasks and maintain documentation and reporting for grants and protocols. The ideal candidate will be self-motivated, organized, and have excellent leadership skills. The position is Monday to Friday, full time with 40 hours weekly.

Job Duties

• Oversees daily operational activities to support productivity and collaboration across multi-site study teams.
• Leads coordination of weekly team meetings by setting agendas, facilitating discussions, and synthesizing site reports.
• Directs task delegation to study staff, including recruitment, data collection, and compliance activities, while tracking completion.
• Guides research team members through training on data systems and protocol adherence; provides support during coordinator meetings.
• Oversees participant recruitment and enrollment across multiple sites in alignment with regulatory and protocol standards.
• Provides oversight in the use of electronic medical record systems such as EPIC and CPRS for participant screening and tracking.
• Maintains responsibility for participant tracking logs and engagement activities.
• Designs and maintains study databases tailored to protocol and sponsor specifications.
• Prepares and submits IRB amendments, renewals, and protocol updates for regulatory review.
• Ensures distribution of regulatory approvals and compliance documentation to all participating sites.
• Prepares and submits required documents to Baylor College of Medicine, the Department of Veterans Affairs, and other agencies.
• Maintains all essential study records, including regulatory binders, correspondence, and audit documentation.
• Prepares teams and documentation for monitoring visits and audit reviews.
• Ensures secure and timely archiving of all study materials.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• IRB submissions and regulatory compliance.
• Multi-site study coordination.
• Extensive research coordination experience.
• Organized, self-motivated, teamwork, works well under pressure, multitasking.