Clinical Study Monitor — Regulatory & Compliance

The University of Texas Medical Branch; Galveston (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

The University of Texas Medical Branch in Galveston is seeking a Research Academic & Clinical staff member to monitor the administrative components and progress of clinical research studies approved by the UTMB IRB. This role ensures the safety of clinical trial participants and maintains the accuracy and integrity of trial data.

You will collaborate with investigators and study staff, develop monitoring plans, coordinate visits, and prepare reports.

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 (preferred).

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 expedite 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 compliance

Clinical research coordination

Communication skills

Team collaboration

Education

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

Master of Science in Nursing or similar discipline

Job description

The University of Texas Medical Branch in Galveston is seeking a Research Academic & Clinical staff member to monitor the administrative components and progress of clinical research studies approved by the UTMB IRB. This role ensures the safety of clinical trial participants and maintains the accuracy and integrity of trial data.

You will collaborate with investigators and study staff, develop monitoring plans, coordinate visits, and prepare reports.