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Baylor College of Medicine · 4 days ago

Senior Clinical Research Associate

Houston, TX

Full-time

Onsite

Mid, Senior Level

4+ years exp

Baylor College of Medicine is seeking a Senior Clinical Research Associate to support and coordinate complex clinical trials in Dr. Christopher Verrico's laboratory. The role involves managing study operations, ensuring regulatory compliance, and supervising research personnel while serving as a liaison among various stakeholders.

EducationHigher EducationPharmaceutical

No H1B

Responsibilities

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