PS Regulatory Coordinator

Details Open Date 10/23/2024 Requisition Number PRN40177B Job Title PS Regulatory Coordinator Working Title PS Regulatory Coordinator Job Grade E FLSA Code Administrative Patient Sensitive Job Code? Yes Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary Full time, Monday – Friday, 8:00 am – 5:00 pm with occasional evenings and weekends required. Shared on-call 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. VP Area U of U Health - Academics Department 00848 - Pediatric Administration Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range $39,300-$68,349 Close Date 01/23/2025 Priority Review Date Job Summary Job Summary The Division of Pediatric Hematology-Oncology, 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 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, Investigator’s 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 Clinical 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 https://benefits.utah.edu/ Responsibilities Essential 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 investigator-initiated 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. 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 follow-through. 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 patient’s status and provide care as described in the department’s policies and procedures manual. Minimum Qualifications Bachelor’s 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 patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive 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. Preferences Type Benefited Staff Special Instructions Summary Additional Information The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually the first day of work). Contact Human Resources at (801) 581-7447 for information. Individuals who previously retired and are receiving monthly retirement benefits from URS are subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules. This position may require the successful completion of a criminal background check and/or drug screen. The University of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients. All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities. The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both. To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/ Online reports may be submitted at oeo.utah.edu https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.