PS Regulatory Coordinator

Job Summary
Job Summary The Division of Pediatric HematologyOncology BMT & Immunology in the University of Utah School of Medicine has an immediate opening for a Regulatory Coordinator. This is an exciting opportunity to be a part of the Research Enterprise team of the Division of Hematology/Oncology. This position supports Bone Marrow Transplant and Immunology clinical trials as well as a myriad of consortium and industry/governmental sponsored trials focused on pediatric cancer. Come be part of the team to help in the fight against childhood cancer! The Regulatory Coordinator Develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements. Supports the Principal Investigator and study team ensuring compliance with all University state and federal regulations that govern clinical research. Prepares applicable submission forms and submits updated documents to the IRB including but not limited to: Amendments Addendums Investigators Brochures Safety Information Form FDA 1572s and informed consent documents. Maintains and accurately files all necessary logs within the regulatory binder(s). Maintains all regulatory files for each trial assigned by maintaining accurate filing and recording of regulatory information. Autonomy creativity and critical thinking skills are strongly encouraged and welcomed. This position will report directly to the Research Manager of the Hematology/Oncology/ BMT Research Enterprise. The University of Utah offers a comprehensive benefits package including: Excellent health care coverage at affordable rates 14.2 retirement contributions that vest immediately Generous paid leave time 11 paid Holidays per year 50 tuition reduction for employee spouse and dependent children Flex spending accounts Free transit on most UTA services Employee discounts on a variety of products and services including cell phones & plans entertainment health and fitness restaurants retail and travel Professional development opportunities Additional benefits information is available at Functions Supports all aspects of regulatory compliance. Prepares facilitates submits and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments administrative changes changes in subject population funding recruitment procedures site changes changes in informed consent or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy. Facilitates and coordinates all aspects of IRB submissions. This includes evaluating protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol. Completes audits and maintains study records materials and databases to ensure compliance with study protocols FDA IRB departmental and university regulations. Prepares regulatory documents including consent forms for submission to research review committees. Communicates with research committees and administrative units project sponsors and project staff to ensure accuracy of regulatory documents and submissions. Tracks study approvals and expirations to ensure uninterrupted project approval. Tracks sponsor and investigatorinitiated amendment notifications and submits amended protocols summaries and consents to the IRB . Submits study renewal applications and study progress reports to the IRB . Coordinates with study sponsor investigator and IRB to complete study closure activities. Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission. Assists in aiding trial activation across disciplines as needed. Recommends and implements regulatory process improvements. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Demonstrates initiative enthusiasm positive attitude teamwork and commitment to the research mission of the department by providing support as needed and where directed. Work Schedule: Full time Monday Friday 8:00 am 5:00 pm with occasional evenings and weekends required. Shared oncall responsibilities. Opportunities for a hybrid telework schedule may be available if supported by operational needs. Employees may need to provide their own home office space internet connection telephone and have the ability to work independently. Problem Solving This position utilizes federal institutional guidelines and requirements to inform and complete submission of regulatory documents. This position also negotiates with University research committees and sponsors to ensure full compliance and communication. Comments This position requires a sophisticated understanding of regulatory requirements. The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and followthrough. Work Environment and Level of Frequency typically required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead. The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patients status and provide care as described in the departments policies and procedures manual. Disclaimer This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to the job.

Minimum Qualifications
Bachelors degree in a research or related area plus two years clinical trials/research experience or equivalency (one year of education can be substituted for two years of related work experience) required; demonstrated human relations and effective communication skills also required. One year of regulatory experience an understanding of medical terminology and technical writing experience preferred. This position is patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.