Clinical Study Monitor, Research, Regulatory, & Compliance (Hybrid)

University of Texas Medical Branch (UTMB)•Galveston, TX

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in healthcare administration, nursing, clinical sciences, or related discipline.
Five years of clinical experience including three years in clinical research
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.
Ability to approach all work activities and interactions with a high level of integrity.

Nice To Haves

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 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.
Adheres to internal controls and reporting structure.
Performs related duties as required.