Research Quality Analyst

Summary

Assists in implementing the established Quality Management (QM) system by performing the elements of the Quality Management Plan (QMP) and training other research personnel in quality management-related activities.

Job Duties

• Collects completed review tools from pharmacy, laboratory, and regulatory personnel when complete.
• Performs research chart audits based on QMP requirements and research center established practices and documents findings on appropriate tools.
• Performs data comparison reviews according to established practices and documents findings on review tools.
• Performs quality control reviews at enrollment and/or vaccine administration clinic visits and documents the results according to established practices.
• Participates in revising the Vaccine Research Center QMP, and the development/revision of protocol specific QMPs, as needed.
• Orients clinic personnel to the QM process, trains them in proper query resolution including source document and eCRF reconciliation and error correction.
• Assists in the development of monthly QM summary reports for each active study, as needed.
• Assists in the development, management, and revision of Standard Operating Procedures.
• Reports directly to the Senior Research Quality Analyst.

Minimum Qualifications

• Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

13404

CA; SN