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Senior Quality Assurance Analyst


Employer: Baylor College of Medicine (BCM)
Location:
Posted: July 30, 2014
Expires: September 26, 2014
Requisition number: 206687KP

Science jobs from Baylor College of Medicine (BCM):
Performs Quality Assurance reviews and coordinates the Quality Assurance/Quality Control (QA/QC) program for the Pediatric Research Resources Office (RRO). The primary purpose of the QA program is to ensure subject safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective action as necessary. The QA evaluation will include evaluation of both the regulatory processes as well as specific subject data.

The Senior QA Analyst in collaboration with the Operation's Manager and RRO Leadership will recommend necessary improvements/changes to the program as dictated by changes to the regulations or the regulatory environment.

The Senior QA Analyst must plan study specific audit deadlines, develop action plans for delinquent or inadequate audit responses and in general help to oversee the QA Program. This includes scheduling audits, notifying the appropriate personnel of the pending audits, conducting and coordinating the audit, and reporting the results back to the stakeholders including the IND holder (if applicable), the PI, the study staff and the RRO leadership.

Monitor protocol compliance and documentation, performs periodic study conduct reviews, and verify clinical research staff competencies. Effectively communicate findings and work with senior leadership to provides suitable recommendations for corrective actions. Set study specific audit goals, plan audit activities and perform yearly assessment of compliance with meeting those goals. Perform process validation related to all Program procedures. Perform on-going training and evaluation of clinical research staff with regard to adherence to relevant clinical research SOPs. Assist in preparing for outside audit/monitoring visits and collection of delinquent data.

Requires Bachelor's degree, Master's preferred and five years of clinical research or laboratory experience. Must have direct auditing experience in quality control or monitoring in clinical research. Preferably, the individual will also have experience developing and implementing a new quality control program within a diverse research environment. Managerial experience specializing in quality assurance or quality control in clinical research and experience training new personnel a plus. Experience with data analysis, with good attention to detail.

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

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