Summary

The Michael E. DeBakey Department of Surgery is seeking a highly motivated and detail-oriented Research Coordinator II to join the Division of Vascular Surgery’s Vascular Intelligence for Translational AI & Learning (VITAL) Lab. The selected individual will be responsible for managing the daily operations of research protocols, including participant enrollment and ongoing monitoring. This position requires ensuring the accuracy of data collection and documentation, maintaining organized records, and upholding the safety and well-being of research participants.

Opportunity for professional growth and advancement based on performance.

Job Duties

• Coordinate day-to-day operations of clinical trials, including sponsor-initiated investigational device clinical trials and other studies as assigned, in compliance with protocols, and regulatory, sponsor, and institutional requirements. The individual should demonstrate strong problem-solving abilities, take initiative, and consistently meet deadlines set by Principal and Co-Investigators, and Manager.
• Strong written communication skills, attention to detail, and ability to manage multiple projects and deadlines.
• The position typically follows standard business hours; however, occasional early mornings, evenings, or weekend work may be required depending on the study protocol.
• Coordinate participant enrollment in collaboration with Principal and Co-Investigators; explains process and procedures to educate participant regarding the research study. Conduct informed consent when appropriately delegated and trained.
• Proficiency in computer software is required, including Microsoft Office and front-end database systems such as EPIC, Medidata, RedCap, and Oracle.
• Ensure accurate and timely data collection and management. Prepare and maintain complete study documentation for research studies, including regulatory binders, source documents, case report forms, and electronic databases.
• Prepare, submit, and maintain IRB documentation, including applications, amendments, continuing reviews, annual reports, and reportable adverse events.
• Ensure timely and accurate adverse events reporting to sponsors, IRB, and regulatory authorities. Maintain detailed and accurate adverse events documentation for audits and monitoring visits.
• Maintain data integrity through timely data entry, query resolution, and audit, monitoring, and device accountability support.
• Order supplies and equipment.
• Perform other job duties as assigned.

Minimum Qualifications

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

Preferred Qualifications

• Nursing background strongly preferred (LVN or BSN).
• Degree in a medical or healthcare-related field preferred.
• Candidates with hands-on clinical experience.
• Familiarity with reading and interpreting medical charts.
• Candidates with medical degrees.