Summary

This Senior Clinical Research Associate position supports and coordinates multiple complex clinical trials within Dr. Christopher Verrico's laboratory located at the Michael E. Debakey Center (MEDVAMC), focusing on substance use, psychopharmacology, and behavioral health. This position will manage the day to day study operations, oversee regulatory compliance, supervise research personnel, and ensure adherence to BCM, MEDVAMC, sponsor, and federal research standards. This position functions with a high degree of independence and leadership, serving as a critical liaison between the principal investigator, sponsors, regulatory bodies, and collaborating institutions. 

Job Duties

• Oversees daily operations for multiple complex clinical research protocols, including Department of Defense, NIH, and FDA-funded studies.
• Supervises, trains, and mentors research staff; coordinates onboarding, delegation of responsibilities, and performance management across multiple active protocols. Leads process improvement and workflow efficiency initiatives.
• Oversees and coordinates subject recruitment, informed consent, and study visit execution; ensures compliance with study inclusion/exclusion criteria. Manages end-to-end execution of research projects.
• Oversees data integrity and management; ensures accurate entry, query resolution, and reporting within required timelines.
• Collaborates with institutional partners (VA, UT Health Science Center, Houston Methodist) to facilitate multi-site operations and compliance.
• Prepares and submits documentation to IRBs, DSMBs, sponsors, and regulatory agencies; maintains IND and FDA submissions as applicable.
• Monitors study progress and adherence to Good Clinical Practice (GCP) guidelines; prepares for sponsor audits and regulatory inspections.
• Develops and implements standard operating procedures (SOPs) for research conduct, specimen handling, and data collection.
• Coordinates specimen processing and shipment to external labs and collaborators.
• Serves as primary contact for sponsor monitors and participates in site qualification, initiation, and monitoring visits.
• Supports grant and contract development activities for ongoing and prospective research initiatives.
• Oversees protocol execution at both BCM and affiliated sites (e.g., MEDVAMC), ensuring compliance with IRB, VA, and FDA regulations.
• Develops and maintains study-specific standard operating procedures and training materials for Dr. Verrico's lab.
• Oversees study start-up through close-out, including protocol development, regulatory submissions, and coordination with sponsors for site qualification, initiation, and monitoring visits.
• Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Master's degree in psychology or closely related field.
• Extensive clinical research experience.