Research Coordinator II (Clinical) - Surgery - Vascular Surgery

Benefits

Qualifications

• •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
• •Proficiency in computer software is required, including Microsoft Office and front-end database systems such as EPIC, Medidata, RedCap, and Oracle
• •Bachelor's degree in a related field
• •Four years of related experience may substitute for degree requirement
• •One year of relevant experience
• •3 more items(s)

Responsibilities

• •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
• •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 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
• •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
• •12 more items(s)