Director of Operations is to organize and oversee the daily operations of the USTMA. They will be the one to ensure that our business is well-coordinated and productive by managing its procedures and coaching its people.The area of responsibility for this role is very wide and thus requires thorough knowledge of various company processes. The ideal candidate must be competent and able to plan many different kinds of operational activities. He/She must be an excellent leader who can discover the most efficient ways to run the business.The goal is to safeguard and augment the efficiency of the company’s operations to facilitate accelerating development and long-term success.Duties/Responsibilities:• Responsible for the direction and coordination of an organization.• Maintain all media for the USTMA, including but not limited to the website, social media, and video hosting accounts• Schedule and host educational seminars for patients• Field all inquiries regarding the organization and direct to the correct party• Establish and interface with financial accounts• Establish and maintain 501c3 status for the organization• Interface with member sites to improve communication and coordination of USTMA activities• Provide hands-on help at a distance and in person when needed to help with the opening of research studies and protocols at each site• Coordinate with sites the transmission to USTMA of needed data and documentation as required for research or regulatory purposes

I have years of intensive clinical research experience. From a coordinator to leader of a rare disease research consortium, I have worked on trials of all types and sizes. I specialize in Rare Disease research with a focus on trial logistics when recruitment is a concern. I am Director of Operations for the United States Thrombotic Microangiopathy Alliance and the Integrity and Compliance officer for a Central Ohio Health system. I was a Lead Research Coordinator for the Benign Hematology Department at Ohio State University, often achieving top or first enrollment in the most complex trials. In each of these roles I was responsible for solving logistical complexities as well ensuring high quality data is recorded. I have coordinated clinical trial implementation at over 20 sites within the United States. I was responsible for contract negotiations, billing compliance auditing, data management, regulatory start up and monitoring. I have served on multiple advisory boards for pharmaceutical clinical trials for study design. My experience makes me uniquely adept at protocol design and implementation.

In accordance with the Mission and Guiding Behaviors; the Integrity & Compliance Officer works collaboratively with Compliance and Legal Services to support the coordination and implementation of the comprehensive Integrity & Compliance Program at Mount Carmel Health System, including Mount Carmel Medical Group and applicable Joint Venture facilities. ICO responsibilities include audit response, risk analysis, data analysis, associate and physician education, policy development, hotline investigations and other duties as assigned.As a member of the Compliance Department, assists with departmental initiatives and coverage as assigned.

In accordance with the Mission and Guiding Behaviors; the Research Revenue Compliance Officer (RRCO) is the key communicator between Revenue Operations and the Office of Research Affairs with a focus on compliance with all Federal and State Regulations as it relates to revenue cycle functions and associated processes impacting revenue. This individual demonstrates problem solving ability and collaboration with key stakeholders. The position focuses on details of documentation, procedures, education and training on requirements inherent in clinical research billing and collection; including review and focus on research documentation, charge capture, and risk analysis. In addition, the RRCO provides an internal auditing function to prevent and solve disputes that have the potential to compromise the organization's ability to bill for research activities in a compliant manner.This includes review of policies, processes, contractual agreements, coverage analysis and budget agreements for clinical research trials.

Responsibilities included recruitment, phlebotomy, data entry, protocol education, communication with principal investigator, and EKG performance. In addition I helped mentor new staff, participated in the interviewing and selection process for new staff, as well as created training documents to help new staff. Protocol development as well as feasibility assessment for upcoming studies also falls under my responsibilities. Also maintain regulatory binder as well as help with budget creation and study start up. I also interact with investigational drug services in order to help establish work flow for new studies.

Functions as a Clinical Research Coordinator within the Division of Benign Hematology within the Department of Internal Medicine; communicates closely with Principal Investigator (PI) and other Key Personnel, as assigned, and reports to PI and Clinical Research Manager in implementation and coordination of clinical research protocols; plans, organizes and coordinates site enrollment processes as part of a multi-site research protocol in TTP; screens, recruits, enrolls and follows subjects in research studies; determines subject eligibility; obtains informed consent; provides education regarding participation in clinical research; performs research study management of subjects; collects, records and manages subject data and inputs information on forms and into databases; answers data query questions; collects, processes and distributes biological specimens at OSU for analysis; tracks samples in transit from other enrolling sites; coordinates status assignments of patient charts with OSU and enrolling site cardiologists; oversees and maintains IRB regulatory files and submits reviews; coordinates internal and external reviews for quality assurance and compliance; assists in developing plans to meet needs of new studies/protocols; oversees communication with enrolling sites; coordinates post-intervention survey; works closely with research faculty and staff to present study protocol information and participates in research meetings; collects information and assists with grant preparation and study presentations; prepares and participates in study monitoring visits; attends conferences, seminars and meetings and may travel to sites to enhance study.