UTMB Faculty Group Practice · 10 hours ago
Clinical Research Coach, Research Administration (Galveston)
Galveston, Texas, United States
Full-time
Onsite
Senior Level
7+ years expUTMB Health is seeking a Clinical Research Coach to mentor and guide clinical research investigators and staff to ensure high-quality research practices. The role focuses on the operational aspects of compliant study conduct, including recruitment, enrollment, and data collection.
Hospital & Health Care
Responsibilities
Review and comprehend the scientific and operational aspects of clinical research protocols, including but not limited to the study purpose, schema, procedures, eligibility criteria, and study timelines
Work closely with assigned investigators and study teams throughout the entire study lifecycle to: Provide insight and feedback on IRB regulatory submission requirements, documents, and overall processes
Provide resources and best practices for developing source documents, protocol specific flowsheets, case report forms (CRFs), enrollment logs and deviation logs
Provide tools, processes, and training to promote regulatory and protocol compliance as it relates to subject recruitment, the consent process, subject eligibility, study visits, subject and regulatory documentation standards
Provide training and review of essential documents and creating/maintaining a regulatory binder
Accompany investigators and study staff for initial consent processes and study visits to provide support and feedback
Review initial study documentation to ensure it is attributable, legible, contemporaneous, original, accurate and complete
Prepare for monitoring and/or audits
Quickly identify when a Sponsor, Investigator or Institution should be alerted to concerns or issues
Collaborate with the Office of Institutional Compliance and the Office of Research Regulations and Compliance
Adheres to internal controls and reporting structure
Performs related duties as required
Qualification
Required
Bachelor's degree and 7 years of experience with interventional clinical research or equivalent
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) or similar certification through a recognized professional clinical research organization, or ability to obtain professional certification within one year of employment
Preferred
Registered Nurse or Medical Degree
Clinical Research Monitor or Coordinator experience
Experience with a Clinical Trial Management System (CTMS), electronic IRB platform and EMR
Company
UTMB Faculty Group Practice
The University of Texas Medical Branch (UTMB) Faculty Group Practice (FGP) is comprised of over 950 faculty physicians and advanced practice providers who drive UTMB’s mission of improving health by delivering innovative education and training, pursuing cutting-edge research, and providing the highest quality patient care.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase