• Job Description

  Req#: 23796
  
  
  
  
  
  
  
  Minimum Qualifications:
  Bachelor’s degree in healthcare administration, nursing, clinical sciences, or related discipline. Five years of clinical experience including three years in clinical research.
  Preferred Qualifications: (if applicable)
  • Master of Science in Nursing or similar discipline.
  
  LICENSES, REGISTRATIONS OR CERTIFICATIONS
  Required:
  • N/A.
  
  Preferred:
  • N/A.
  
  SUPERVISION
  Received: Director, Research Integrity & Regulatory Affairs
  Given: N/A
  JOB SUMMARY:
  Monitors the administrative components and progress of clinical research studies approved by UTMB Institutional Review Board (IRB). Ensures the safety of clinical trial participants and maintains the accuracy and integrity of trial data.
  Job Duties:
  • Develops and maintains highly collaborative working relationships with internal teams, investigators, and study staff.
    
  • Assist with the development and dissemination of study-related documents as needed by the research community.
    
  • Establish monitoring plan for IRB-approved studies including UTMB investigator-initiated projects.
    
  • Coordinate and conduct monitoring visits with study teams.
    
  • Ensures timely completion of monitoring activities and creates reports summarizing relevant findings from monitoring visits.
    
  • Asses the conduct of clinical studies by monitoring compliance with the protocol, federal regulations, and ICH guidelines as applicable, and to ensure safety of human participants, research related evaluations and tests are conducted following the protocol and regulatory requirements and compliance with regulatory agency requirements and institutional policies relating to human participant research.
    
  • Initiate actions necessary with principal investigators and research teams to correct potential issues identified during monitoring visit, schedule meetings with team to discuss issues concerning scientific integrity and document the findings and action plans.
    
  • Work with the Office of Research Integrity and Regulatory Affairs 5b(RIRA) and Principal Investigator to escalate study promptly.
    
  • Notify investigators of any safety or human subject's protection-related findings promptly.
    
  • Assist in preparing study teams for inspections and with audit responses when requested.
    
  KNOWLEDGE/SKILLS/ABILITIES
  • Ability to approach all work activities and interactions with a high level of integrity.
    
  • Knowledge of regulatory and compliance requirements for clinical research studies including but not limited to, US CFR, ICH, GCP, GDP.
    
  • Demonstrated excellent presentation, communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
    
  • Excellent time management and prioritization of tasks to accomplish goals and meet study timelines and deliverables efficiently and successfully.
    
  • Proven ability to foster effective relationships with teams, functions, partners, and key stakeholders.
  Marginal or Periodic Functions:
  • Adheres to internal controls and reporting structure.
  • Performs related duties as required.
  WORKING ENVIRONMENT/EQUIPMENT
  Standard office environment at UTMB’s main campus or other study locations
  Salary Range: Actual salary commensurate with experience or range if discussed and approved by hiring authority.
  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 VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
  Compensation
  
  
  
  
  
  
  
  
  

• About the company

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