Hybrid Clinical Study Monitor: IRB & Compliance

Utmb; Galveston (TX); Hybrid; USD 70,000 - 110,000; Full time

Job summary

UTMB Health is seeking a Clinical Study Monitor to oversee administrative and regulatory aspects of clinical research across IRB-approved studies. This hybrid role focuses on safety, data integrity, and compliance with US CFR, ICH, and GCP guidelines.

The position requires a strong background in clinical research, collaboration with investigators, and ability to coordinate monitoring visits and prepare reports for regulatory review.

Qualifications

• Bachelor’s degree in healthcare administration, nursing, clinical sciences, or related discipline.
• Five years of clinical experience including three years in clinical research.
• Master of Science in Nursing or similar discipline.

Responsibilities

• 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.
• Assess 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 elevate 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.

Skills

Regulatory knowledge

Communication skills

Time management

Problem-solving

Education

Bachelor's degree in healthcare administration, nursing, clinical sciences, or related

Master of Science in Nursing

Job description

UTMB Health is seeking a Clinical Study Monitor to oversee administrative and regulatory aspects of clinical research across IRB-approved studies. This hybrid role focuses on safety, data integrity, and compliance with US CFR, ICH, and GCP guidelines.

The position requires a strong background in clinical research, collaboration with investigators, and ability to coordinate monitoring visits and prepare reports for regulatory review.