Clinical Research Monitor - School of Public Health (Finance)
What we do here changes the world. UTHealth Houston is Texas' resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That's where you come in.
Once you join us you won't want to leave. It's because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you'd expect from a top healthcare organization (benefits, insurance, etc.), plus:
- 100% paid medical premiums for our full-time employees
- Generous time off (holidays, preventative leave day, both vacation and sick time - all of which equates to around 37-38 days per year)
- The longer you stay, the more vacation you'll accrue!
- Longevity Pay (Monthly payments after two years of service)
- Build your future with our awesome retirement/pension plan!
We take care of our employees! As a world-renowned institution, our employees' wellbeing is important to us. We offer work/life services such as...
- Free financial and legal counseling
- Free mental health counseling services
- Gym membership discounts and access to wellness programs
- Other employee discounts including entertainment, car rentals, cell phones, etc.
- Resources for child and elder care
- Plus many more!
Position Summary:
Provides oversight of research protocols to ensure adequate education and compliance with regulations concerning human subject protection. Assists in the development and implementation of a monitoring program for research involving human subjects that will be based on risk-based analysis.
The Coordinating Center for Clinical Trials (CCCT) is one of the centers within UT-School of Public Health and has 50-plus years' experience in clinical trial leadership, design, management, execution, analysis, and dissemination (both NIH and industry-sponsored). The CCCT has played a leadership role in medical research by serving as a coordinating center for 25+ nationwide multicenter clinical trials. Key personnel include statisticians, physicians, epidemiologists, project managers, Clinical monitors, information technology personnel, statistical programmers, safety and regulatory personnel, as well as financial and administrative teams. The group has extensive experience in managing both large and small scale multicenter trials and research networks, with proficiency in project management, administration, database development, and analytical support.
Position Key Accountabilities:
- Coordinates, schedules, and implements clinical research reviews.
- Reviews documentation related to study protocol(s) that may include management of study documentation, patient enrollment, data collection, event reporting, follow-up and regulatory reporting requirements.
- Establish with the informed consent process, protocol adherence, adverse event reporting, and regulatory requirements for research involving human subjects on an ongoing basis.
- Reports to the study leadership, Executive and Steering Committees, or Institutional Review Board (IRB) on monitoring activities.
- Assists with the development and implementation of a risk assessment process.
- Performs periodic review of documentation and meetings.
- Evaluates current procedures, policies and practices, and implements alternate methods designed to assure conformity with regulatory requirements for human subjects.
- Manages the continuing review process for all approved protocols.
- Coordinate with study leadership to determine and implement appropriate remediation for violations of study protocol.
- Interacts with and builds good working relationships with research investigators and staff and with departmental personnel on an ongoing basis.
- Attends professional meetings and maintains certification as appropriate.
- May be required to travel to study sites.
- Other duties as assigned.
Certification/Skills:
- Effective analytical skills.
- Good communication, both verbal and written.
- PC knowledge, especially in the area of word processing and spreadsheets.
Minimum Education:
- Bachelor's degree in a related field, preferably in nursing.
Minimum Experience:
- Three years of clinical trial experience or clinical trial monitoring.
Physical Requirements:
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.
Security Sensitive:
This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code ยง 51.215
Residency Requirement:
Employees must permanently reside and work in the State of Texas.
