Clinical Research Quality Analyst

Summary

Performs Quality Assurance /Quality Control (QA/QC) reviews for the Pediatric Research Resources Office (RRO) to ensure 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

• Assist with coordination of the Quality Assurance/ Quality Control Program, including providing leadership, guidance and training to junior staff.
• 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 PI, 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 in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Four years of related experience.
• Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP), CCRA (Certified Clinical Research Associate) or Certified Clinical Research Coordinator (CCRC) is a plus.
• Working knowledge of FDA regulations, Good Clinical Practice, ICH guidelines and industry recommendations for the conduct of clinical trials.
• Ability to identify 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 control review and reporting.
• Ability to multitask and flexibility to work with varied documents and assignments, good attention to detail.
• Ability to work effectively with others and demonstrate teamwork.

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

6406

CA; CH