This position reports to the Institutional Official and IRB Director and serves as the primary contact for compliance issues involving human subject research. The position is responsible for the continued development and implementation of a post-IRB approval monitoring program of research studies involving human subjects, research education program, as well as other quality improvement activities. As an auditor, develops and implements the research audit plan to include the performance of audits of research studies to ensure compliance with federal and state law and regulations as well as institutional standard operating procedures relating to the conduct of research studies.
- Conducts reviews in response to allegations and findings of noncompliance with federal and state regulations and standard operating procedures as well as sponsor requirements (protocol).
- Conduct systematic reviews that evaluate researchers' and their study team's compliance with approved protocols.
- Compile reports on audit/monitoring findings. Recommends corrective actions to researchers and the IRBs as required. Reports the findings when appropriate to IRB leadership and others as appropriate.
- Receives and handles compliance issues and complaints, and may refer to such items when necessary to the appropriate reporting manager.
- Ensures that the implemented research audit program is appropriate in scope, that identified issues are corrected and that all investigators are educated.
- Conducts audits to ensure compliance with the study or sponsor Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and expectations for data accuracy and completeness. Develops, executes and maintains audit schedules according to the need(s) of the project.
- Works with the investigator and study team to identify the root cause and implements corrective and preventive action plans for identified areas of noncompliance.
- Assists in the preparation for external audits by regulatory agencies or sponsors. Develops reports for management as requested.
- Participates in training on the research process. Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work.
- Helps develop and manage research education program.
- Reviews adverse events reported by the research teams. Assures that forms are completed and signed by the investigator and that the risk/benefit ratio is not increased. Makes appropriate notifications if the risk is increased.
- Maintains current knowledge of applicable federal and state laws, standard operating procedures, GCP, etc.
- Assists in the development and implementation of appropriate organizational policies and operating procedures and review of the monthly submission and preparation of IRB agenda (if appropriate).
- Attends IRB meetings to ensure compliance and to report any pending compliance issues and/or their remedy.
- Assist with all other duties as needed.
- Bachelor's degree; and/or Master's degree preferred.
C. Licenses, Registrations, or Certifications
- A minimum of five (5) years clinical research experience; with two (2) years of IRB, audit and compliance experience.
- Clinical research or compliance certification (CCRP, CCRC, CHRC, CIP, CIM, etc.) preferred and/or obtained within 1 year of employment.
Good Clinical Practices (Gcp)
Standard Operating Procedure
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The two Congregations of the Sisters of Charity of the Incarnate Word in Houston and San Antonio share a common mission of providing the healing ministry of Jesus Christ, which began more than 130 years ago. The shared legacy of the two Congregations dates back to 1866 when three Sisters Religious came from France in response to a call from Catholic Bishop Claude M. Dubuis to come to Texas to help care for the sick and infirm. In the leading port city of Galveston, the Sisters founded the Congregation of the Sisters of Charity of the Incarnate Word and opened the first Catholic hospital in the state. In 1869, three members of the Congregation traveled to San Antonio and established Santa Rosa Hospital. Due to the distance between the cities and the problems of transportation at the time, the Congregation in San Antonio became a separate order with the same name as its founding Congregation.
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In 1972 Space Center Memorial Hospital opened to serve the 55,000 community members surrounding NASA Manned Spacecraft Center. The goal of the new hospital was "to return to the people of our country the benefits in the form of health service dividends produced from space exploration."
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