Senior Clinical Research Quality Analyst
The Dan L Duncan Comprehensive Cancer Center (DLDCCC) is seeking a Sr. Research Quality Analyst in the Clinical Trials Support Unit. The purpose of this position is to coordinate and ensure that clinical research within DLDCCC undergoes adequate and thorough oversight.
This position serves as the DLDCCC Patient Safety Officer for clinical research; in this regard, the position will coordinate the DLDCCC oversight committees. This position also works alongside the QA/QC Team to assist in quality assurance activities, such as internal monitoring of research studies and review/preparation of reports. The Sr. Research Quality Analyst coordinates the oversight of DLDCCC clinical research by these committees: Clinical Research Leadership Committee (CRLC); Protocol Review and Monitoring Committee (PRMC); Data Review Committee (DRC); Data and Safety Monitoring Board (DSMB). This position is responsible for coordinating the activity of these committees.
- Preparing the agenda and meeting materials, scheduling meetings, receiving and routing submissions to the committee members, documenting discussions, preparing minutes, and sending correspondence from the committees to investigators.
- Maintaining accurate records and documentation of protocol oversight activities, including correspondence, committee actions, and submitted data.
- Reviewing and assessing protocols, consent forms and data safety monitoring plans within each protocol.
- Establishing and maintaining records for implementation of the approved plans.
- Receiving and routing reporting SAE reports for review by cancer center leadership; tracking the review and determination of the reports.
- Monitoring SAEs and unanticipated problems for review by the DLDCCC clinical research leadership.
- Notifying the appropriate oversight committee of SAEs, deviations, and other unanticipated problems.
- Ensuring that protocols adhere to approved Data and Safety Monitoring Plans.
- Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
- Five years of relevant experience.
- Master's degree and three years of relevant experience may also be considered.
- Experience in clinical research regulatory or clinical research QA.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.