Title:  Lead, Clinical Research - Vaccine Development and Evaluation

Summary

The Department of Pediatrics Division of Tropical Medicine and Texas Children's Hospital Center for Vaccine Development (TCH-CVD) seek a highly motivated Clinical Research Lead to work on vaccine clinical trial development and implementation. The purpose of the position is to lead the activities of responsible research work in clinical trials management, coordination, and oversight within the Chagas clinical development leadership team. The project will primarily focus on management and coordination with collaborative members of the chagas vaccine consirtium (i.e., clinical leadership team, clinical site, study product and lab site etc). The Clinical Research Lead is responsible for the day-to-day management activities. Ensures accurate documentation and organization for study files (currently on a Phase 1 clinical trial soon to be implemented). We expect that the Clinical Research Lead will contribute to other research projects within the Division of Tropical Medicine as needs arise and contribute to a high-paced environment with an established team.

TCH-CVD at Baylor College of Medicine is one of the leading vaccine development centers in the world developing low-cost effective vaccines against neglected tropical and emerging diseases that can be used in low- and middle-income countries.Our Chagas Disease Vaccine Product Development Partnership Program is in preparation to transition a Chagas disease vaccine prototype into a Phase 1 clinical trial in Mexico.TCH-CVD is the coordinating project manager of the program and seeks the hire of a dedicated Clinical Research Lead with experience in clinical trial management and oversight to coordinate with members of the partnership consortium to support the daily activities of the project.

Job Duties

• Designs and drafts pre-clinical study protocols and informed consent forms; assists with protocol approvalprocess. Develops, reviews, and revises standard operating procedures.
• Oversees the timely execution of key deliverables and identifying critical risk areas.
• Prepares and submits regulatory compliance documents.
• Supports daily operations for clinical research and/or clinical trial(s).
• Consults with the Principal Investigator (PI) and collaborators regarding research data.
• Collaborates with study team locally, abroad and at the clinical and laboratory sites.
• Consults with collaborators to ensure study time-points are met.
• Collects, evaluates, enters and tracks data related to management of the study.
• Provides appropriate and timely responses to management requests.
• Submits reports to complaisance offices and/or regulatory agencies as applicable.
• Assists with completion of protocol-specific documents.
• Monitors protocol timeline compliance and appropriately communicates needs to stay on timeline.
• Establishes study files and prepares and oversees study-related documentation.
• Creates and maintains research charts.
• Updates internal and external databases per departmental, sponsor, or study requirements.
• Precepts new clinical research staff.
• Prepares study-specific reports and queries for investigators and administrators.
• Effectively prioritizes and manages work activities according to study protocol.
• Volunteers to assist team with overflow duties.

Minimum Qualifications

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

Preferred Qualifications

• English/Spanish bilingual or fluency in Spanish (oral, written, spoken)
• Master's Degree
• Familiar with the clinical research compliances and regulations of the Mexican Government's regulatory body (COFEPRIS)