Who Are We & What Do We Do?

Centralized Communication

Susan Koenig, Director of Compliance & Quality and Compliance Officer for the School of Medicine, works to deliver a comprehensive compliance program that promotes a culture of compliance within the School of Medicine. Susan assists the School’s leadership by operationalizing the strategic plan for compliance, investigating potential non-compliance, performing periodic audits of activities within the School, delivering a compliance training program, and collaborating with other compliance units on the campus and within the system to minimize overall risk.

Research visit claims; continuing education

Pam Buhr, Administrative Associate for Research Billing, monitors research subject claims in the billing system on a daily, weekly and monthly basis. Pam provides a link between the clinical trials support staff and the patient accounting staff, helping resolve claims questions and making sure research claims are paid correctly. Anyone who has a question about a research claim should contact Pam at 882-8957. In addition, Pam organizes the training schedule, coordinates CE/CME certificate processing with the SON, prepares training materials and PowerPoint presentations, maintains the Sharepoint Compliance & Quality web version of Orientation and compliance resources, and provides administrative support.

Monitoring and auditing programs

Laura Wright, Healthcare Compliance Coordinator, is responsible for the monitoring and auditing program for clinical research. Laura assists investigators and their support staff in navigating regulatory requirements and minimizing compliance risk. Audits are conducted in conjunction with the network of compliance programs that oversee research in the School of Medicine. The audit programs are continuously modified to address areas of concern. The Healthcare Compliance Coordinator participates in planning and delivering training programs and serves as a resource for staff with regulatory questions.

Research participant advocacy

Jeanette Linebaugh, Research Participant Advocacy Coordinator, provides direct oversight of the informed consent process and other clinical trials activity, communicates with participants and trains investigators and support staff. Jeanette assists investigators in reviewing and determining appropriate action with regard to adverse events, reviews protocols with investigators and their teams and participates in developing data safety and monitoring plans. She maintains a presence in clinical trials areas and assists participants and their families. In her role as Advocate, Jeanette conducts training programs for the community as well as investigators and their staff and maintains frequent communication with the IRB and the Office of Clinical Effectiveness.