Performs Quality Assurance reviews and coordinates the Quality Assurance/Quality Control (QA/QC) program 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 evaluation will include evaluation of both the regulatory processes as well as specific subject data.Job Duties
- Coordinate the RRO Quality Assurance/ Quality Control Program, including providing leadership, guidance and training to junior staff.
- Set study specific audit goals, plan audit activities and perform yearly assessment of compliance with meeting those goals.
- Schedule audits, notifying the appropriate personnel of the pending audits, conducting and coordinating the audit, and reporting the results back to stakeholders including the IND holder (if applicable), the PI, the study staff and RRO leadership.
- Ensure procedures meet or exceed all relevant institutional, state and federal requirements for the conduct of clinical research.
- Perform process validation related to all Program procedures.
- Monitor protocol compliance and documentation, perform periodic study conduct reviews, and verify clinical research staff competencies.
- Prepare reports for Investigators and clinical research teams.
- Effectively communicate findings and work with senior leadership to provide suitable recommendations for corrective actions.
- Assist in preparing for outside audit/monitoring visits and collection of delinquent data.
- Recommend improvements and changes to the program as dictated by changes in regulations.
- Assist with development, distribution, and maintenance of standard operating procedures (SOPs) for all study activities.
- Develop and train new clinical research operations personnel in standard practices.
- Perform on-going training and evaluation of clinical research staff with regard to adherence to relevant clinical research SOPS.
- Assist with clinical research educational activities for the section.
- Required: Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.
- Required: Two years of relevant experience.
- None required.
Bachelors degree in basic sciences, health sciences, nursing, pharmacy or a related field. Masters degree preferred. Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP), CCRA (Certified Clinical Research Associate) or Certified Clinical Research Coordinator (CCRC) a plus.Other
- A 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. Ability to relay information tactfully, clearly and effectively to a diverse set of constituents. Understanding of the sensitivity of quality control review and reporting.
- Experience in training new personnel. Managerial experience specializing in quality assurance or quality control in clinical research is a plus.
- Experience with data analysis, with good attention to detail.
- Ability to multitask and flexibility to work with varied documents and assignments.
- Ability to work effectively with others and demonstrate teamwork.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
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