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Title:  Quality Assurance and Control Associate

Division:  Pediatrics
Schedule:  Monday - Friday, 8:00 a.m. - 5:00 p.m.
Work Location:  Houston, TX
Salary Range:  $56,895 - $63,000
FLSA Status:  Exempt
Requisition ID:  8259

Summary

The Quality Assurance and Control Associate monitors study activities to ensure compliance, subject safety, verify accurate data collection, identify problem areas, and work with appropriate individuals to implement corrective actions as necessary. The QA/QC evaluation will include review and assessment of both the regulatory processes as well as specific subject data.

 

Job Duties

  • Manage/Coordinate the QA/QC program to ensure that implementation and prescribed activities are carried out in accordance with specified objectives.
  • Assist with coordination of the Quality Assurance/ Quality Control Program, including providing leadership, guidance and training to junior staff.
  • Develop, perform and manage quality assurance activities.
  • Schedule audits, set study specific audit goals, plan audit activities, notify the appropriate personnel of the pending audits, conduct and coordinate the audits, and report the results back to stakeholders including the IND holders (if applicable), the Pl, the study staff and leadership.
  • Review regulatory records, pharmacy documentation and subject research charts to ensure they meet or exceed all relevant institutional, state and federal requirements for the conduct of clinical research.
  • Communicate findings and work with leadership to provide suitable recommendations for corrective actions.
  • Perform evaluation of clinical research staff with regard to adherence to GCP and relevant clinical research SOPs.
  • Assist in preparing for outside audit/monitoring visits and collection of delinquent data.-
  • Assist with development, distribution, and maintenance of standard operating procedures (SOPs) for all RRO activities.
     

Minimum Qualifications

  • Bachelor's degree.
  • Two years of relevant experience.

Preferred Qualifications

  • Bachelor's degree in a scientific or healthcare related field.
  • Certification is a plus (RAC, CCRP, CCRA, CCRC).
  • Working knowledge of FDA regulations, Good Clinical Practice, ICH guidelines and industry recommendations for the conduct of clinical trials.
  • Ability to indentify inconsistencies and discrepancies in study documentation and develop solutions to resolve issues.
  • Excellent written, verbal and presentation skills.
  • Understanding of the sensitivity of quality assurance/quality controle review and reporting.
  • Ability to mutitask and flexibility to work with varied documents and assignments, good attention to detail.

 

 

 

 

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

 8259

CA