Clinical Research Coach (Research Administration - Galveston)

Minimum Qualifications:
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.

Preferred Qualifications: 

• Nursing or Medical Degree
  
• Clinical Research Monitor or Coordinator experience
  
• Experience with a Clinical Trial Management System (CTMS), electronic IRB platform and EMR
  

LICENSES, REGISTRATIONS OR CERTIFICATIONS
Required:
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) 
or similar certification through a recognized professional clinical research organization.
Preferred: 
• Registered Nurse

Job Summary: 
The primary focus of the Clinical Research Coach is to provide mentorship, instruction and guidance to clinical research investigators, nurses, coordinators, and other study staff to promote high quality research and implement best practices. This position focuses on the operational aspects of compliant study conduct including recruitment, enrollment, consent process, study visit completion, source documentation, data collection and reporting. 

Job Duties:

• 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: 

1. Provide insight and feedback on IRB regulatory submission requirements, documents, and overall processes. 
   
2. Provide resources and best practices for developing source documents, protocol specific flowsheets, case report forms (CRFs), enrollment logs and deviation logs. 
   
3. 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. 
   
4. Provide training and review of essential documents and creating/maintaining a regulatory binder. 
   
5. Accompany investigators and study staff for initial consent processes and study visits to provide support and feedback. 
   
6. Review initial study documentation to ensure it is attributable, legible, contemporaneous, original, accurate and complete. 
   
7. Prepare for monitoring and/or audits. 
   
8. Quickly identify when a Sponsor, Investigator or Institution should be alerted to concerns or issues. 
   
9. Collaborate with the Office of Institutional Compliance and the Office of Research Regulations and Compliance. 
   

KNOWLEDGE/SKILLS/ABILITIES
• Working knowledge of 45CFR46 (Common Rule); 21CFR11, 50, 54, 56, 312, 600, 812; ICH E6
• Strong communication and collaborative skills
• Clear and concise writing skills
• Professionalism 

Marginal or Periodic Functions:
• Adheres to internal controls and reporting structure.
• Performs related duties as required.

WORKING ENVIRONMENT/EQUIPMENT
• Standard hospital, clinical, and/or laboratory areas where clinical research may occur
• Standard office environment
• Standard office equipment. Microsoft Office Suite

Any qualifications to be considered as equivalents in lieu of stated minimums require the prior approval of the Vice President for Human 
Resources and Employee Services. The University Of Texas Medical Branch at Galveston is an Equal Opportunity / Affirmative Action University. 
Specific job requirements or physical location of some positions allocated to this classification, may render this position security sensitive, and 
thereby subject to the provisions of Section 51.215, Texas Education Code.

Salary Range:  Actual salary commensurate with experience or range if discussed and approved by hiring authority.