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Title:  Manager, Clinical Research

Division:  Office of Research
Schedule:  Monday - Friday, 8:00 am - 5:00 pm
Work Location:  Houston, TX
Salary Range:  $77,029 - $100,000
FLSA Status:  Exempt
Requisition ID:  9024

Summary

The Clinical Research Manager position is within the Office of Clinical Research (OCR), which falls under the umbrella of the BCM Office of Research. This position provides a stimulating work environment, with opportunities for a College-wide perspective on the breadth and depth of clinical research being conducted at BCM. The Clinical Research Manager is responsible for direct management, mentoring, and well-being of clinical research support staff and provides centralized support to Principal Investigators (PIs) from multiple departments and a variety of disease areas across BCM. 

Job Duties

  • Manages and oversees OCR research portfolio, performing feasibility of incoming studies, managing pre & post award study accounts, liaising with PIs, overseeing data collection and documentation activities, and providing OCR cross-coverage.
  • Schedules, coordinates, and participates in the internal feasibility meeting, pre-site visit and site initiation visits.
  • Manages financial aspects of clinical trials, including but not limited to development and negotiation of study budgets, pre and post award financial management.
  • Implements departmental and institutional SOPs, participates in continuing review and renewal of SOPs.  
  • Ensures institutional and federal compliance by following institutional, Sponsor, and FDA SOPs and policies, interfacing with regulatory bodies as needed. 
  • Supports investigators and clinical research staff with reporting, study monitoring, and site visits.
  • Develops, implements, and monitors research protocols, procedures, and processes.
  • Oversees data collection and documentation activities by regular chart reviews; queries databases for timeliness and completion of entries, and prepares reports; manages compliance documentation.
  • Supervises clinical research and administrative staff; provides training and guidance on regulations and best practices. 
  • Provides guidance to department and BCM leadership on relevant clinical trial projects and development.  
  • Manages a study coordination team across geographically diverse locations across the Texas Medical Center.

Minimum Qualifications

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

Preferred Qualifications

  • Clinical trial drug and device experience.
  • Therapeutic clinical trial experience.
  • Clinical trial budget development and negotiation experience.
  • Previous management experience in clinical research, managing trials from multiple PIs.
  • Ability to manage up to 15 different PIs, manage a study team that is scattered across the campus, multiple new study requests per month, and a view on development and growth of team capacity to accommodate the growing clinical research agenda of the College. 

 

 

 

 

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

 9024

CA