Ms. Kristin Bialobok is the Director of Clinical Research Compliance at The University of Texas MD Anderson Cancer Center (MDACC) in Houston, Texas. Ms. Bialobok earned a Bachelor of Science in Nursing from The University of Texas Medical Branch at Galveston and a Master of Science in Nursing with an emphasis in Clinical Research Management from Duke University School of Nursing. In addition, she is certified as both a Clinical Research Coordinator and Clinical Research Associate by the Association of Clinical Research Professionals.

As Director of Clinical Research Compliance, Ms. Bialobok is responsible for the assessment of a system of controls designed to maintain standards associated with clinical research protocols. She participates in the creation of clinical research standards and policies and acts as an advisor/consultant to institutional clinical research personnel involved in protocol management; in addition, she directs the process of audits of clinical research protocols conducted within the institution. Ms. Bialobok oversees the communication of audit results to principal investigators, research personnel, and the Quality Assurance Committee and generates and analyzes quality indicator reports for the Vice President of Compliance. Ms. Bialobok is active in designing and delivering monthly training courses for clinical research faculty and personnel. She administers the Ombudsman service for the Vice President of Research Administration, oversees institutional processes involving MDACC-sponsored IND trials, and coordinates all institutional research involving the National Cancer Institute.

During her residency at MDACC, Ms. Bialobok developed standard operating procedures specific to the conduct of MDACC IND-sponsored studies. She coordinated and conducted investigator meetings to education research faculty and staff. Ms. Bialobok also assisted in the development of a proposal and cost analysis to allow external site participation in MDACC IND-sponsored studies and assisted in the initiation of a pilot program for allowing outside site participation in MDACC IND-sponsored studies.

Ms. Bialobok's session - B5: Clinical Trials: Should You Audit or Should You Monitor?