Summary

The Clinical Research Supervisor for the Fetal Center Research Team will work independently to manage and lead operations of clinical research, drug and device trials under the supervision of the Research Operations Manager and Principal Investigators. They will ensure standard operating procedures are followed and work alongside the Research Operations Manager of the Fetal Center Research Team to build a robust research support team to assist our six principal investigators in the OB/GYN department, four principal investigators from two other departments within Baylor College of Medicine and forty-four co-investigators from ten different departments within Baylor College of Medicine. Provide guidance to the Fetal Center Research Team in determining participation in new study trials and allocate necessary resources for each project. Create learning modules to train and provide guidance and supervision to less experienced staff. Promote and recruit research participation in the fetal center clinical, drug, and device trials. Manage and maintain data integrity for all clinical research in the fetal center.

This position offers the opportunity for a hybrid schedule following a successful training period. This position offers flexible hours, allowing you to start between 7-9 AM and finish between 4-6 PM, based on an 8-hour workday.

Job Duties

Protocol/Project Management: 

• Assist investigators in the overall planning and conduct of clinical trials. 
• Maintain mandatory federal regulatory files with study sponsors. 
• 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.  
• Supervises clinical research staff in the day-to-day operations.

Study Management Responsibilities: 

• Coordinates research staff schedules and monitors workloads
• Train research coordinators to recruit, screen, and enroll research subjects. 
• Resolve all issues related to research study protocols. 
• Coordinates new study visits 
• Ensure staff are consenting subjects to research protocols following Good Clinical Practice guidelines. 
• Appropriate handling and distribution of investigational products to subjects. 

Data Management Responsibilities: 

• Manages and maintains data integrity for all clinical trials.
• 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.

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Bachelor’s degree. No experience required with bachelor’s degree.
• Previous experience in obstetrics.
  Previous supervisory experience.
• CCRP certification.
• FDA Sponsor-Investigator Initiated Trials.
• Familiarity with EPIC/EMR.
• Proficiency with Microsoft Excel software and REDCap database.
• Working knowledge of central and local IRBs such as WIRB, Advarra etc.