Summary

The Fetal Center Research team collaborates with Texas Children's Hospital Pavilion for Women, specializing in fetal intervention clinical trials. Currently, we are actively seeking a full-time senior research coordinator experienced in managing sponsor-investigator trials and multi-center collaborative research projects. The ideal candidate should be a motivated individual with a clinical research background, capable of thriving in a fast-paced, multi-disciplinary environment and possessing keen attention to detail. This key team member will coordinate day-to-day research protocol activities, overseeing participant screening, enrollment, and monitoring while ensuring precise data collection, documentation, organization, and participant safety. Additionally, they will be responsible for supervising, scheduling, and directing less experienced research personnel, operating independently to lead all facets of clinical research, including drug and device trials, collaborating with the Research Operations Manager and Principal Investigators to establish strategic research aims and a robust research support team.

Job Duties

Protocol/Project Management:

• Assist investigators in the overall planning and conduct of clinical trials.
• Maintain mandatory federal regulatory files with study sponsors.
• Monitor IRB and FDA submissions and respond to requests and questions with central and local IRBs and the FDA.
• Initiate and manage multi-center site participation and regulatory duties for multiple national and international data registries for various fetal anomalies.
• Provides leadership for all studies/trials assigned, develops, and implements policies and procedures, and identifies and implements corrective actions/process when required.
• Interact with study sponsors and monitors and reports SAEs and resolves study queries.

Study Management Responsibilities:

• Train research coordinators to recruit, screen, and enroll research subjects.
• Audit of study trial records and specimen collections.
• Resolve all issues related to research study protocols.
• Evaluate subjects for study eligibility and continued participation in the study.
• Ensure staff are consenting subjects to research protocols following Good Clinical Practice guidelines.
• Perform venipuncture, neonatal biometric measurements, specimen collections and processing.
• Appropriate handling and distribution of investigational products to subjects.

Data Management Responsibilities:

• Oversees the data management of studies ensuring accurate study subject documentation.
• Entering subject data into all required federal, state, and local electronic data collection systems.
• Oversee participation in multiple data registries and multi-center approved studies through the North American Fetal Network Collaboration to remain in compliance with participation guidelines for approved NAFTNet centers.

• Performs other job duties as assigned.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Five years of relevant experience.

Preferred Qualifications

• Master's degree in a related field.
• CCRP certification
• Self-directed, independent and organized.
• Effective communication skills, both orally and in writing.
• Experience with computer spreadsheets and database management (experience with developing and maintaining databases in RedCap preferred).
• Ability to understand and implement patient studies and protocols.
• Strong interpersonal skills necessary to manage less experienced research personnel and coordinate research studies between a multi-disciplinary research team.