Clinical Study Monitor

3 weeks ago

Galveston, United States UTMB Health Full time

**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.

**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.

**Preferred Experience**:
Two years of previous clinical trial monitoring experience preferred.

**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.
- Assist in preparing study teams for inspections and with audit responses when requested.

**Salary Range**:
Commensurate with experience.

Pay: $72,308.00 - $110,000.00 per year

**Benefits**:

- 401(k)
- Employee assistance program
- Flexible spending account
- Health savings account

Experience level:

- 5 years

Schedule:

- 8 hour shift
- Night shift
- Weekends as needed

School type:

- University

**Experience**:

- Teaching: 1 year (preferred)

License/Certification:

- Teaching Certification (preferred)

Ability to Commute:

- Galveston, TX 77555 (preferred)

Ability to Relocate:

- Galveston, TX 77555: Relocate before starting work (required)

Work Location: In person

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