Clinical Research Coach, Research Administration (Onsite)

The University of Texas Medical Branch; Galveston (TX); In loco; USD 75.000 - 110.000; Tempo pieno

Descrizione del lavoro

The University of Texas Medical Branch in Galveston, TX is seeking a Clinical Research Coach to mentor investigators, nurses, coordinators, and staff to promote high-quality research and implement best practices.

The role focuses on operational aspects of compliant study conduct, including recruitment, consent, source documentation, data collection and reporting, with emphasis on regulatory compliance and study timelines.

Competenze

• Bachelor's degree and 7 years of experience in interventional clinical research.
• CCR P or CCRC or similar certification or ability to obtain within one year of employment.
• Willingness to obtain professional certification if not already certified.

Mansioni

• Mentor investigators, nurses, coordinators, and staff to promote high-quality research.
• Guide operational aspects: recruitment, consent, visits, source documents, data collection, and reporting.
• Support regulatory and IRB processes and maintain study regulatory binders.

Formazione

Bachelor's degree

Strumenti

CTMS

Electronic IRB platform

EMR

Descrizione del lavoro

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, or ability to obtain professional certification within one year of employment.

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, or ability to obtain professional certification within one year of employment.

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, or ability to obtain professional certification within one year of employment.

Preferred:

• Registered Nurse.

Job Description:

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:
  
  
  
  • 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.

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.

Salary Range:

Commensurate with experience.

EQUAL EMPLOYMENT OPPORTUNITY:

UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

Primary Location

United States-Texas-Galveston

Work Locations

0342 - Research Building 6

Job

Research Academic & ClinicalRegular

Shift

Standard

Employee Status

Non-Manager

Job Level

Day Shift