Regulatory Affairs Specialists (Life Sciences)

Regulatory Affairs Specialists (Life Sciences) Job Summary Develops and coordinates the submission of regulatory documents for the Population Science Trials Office at Huntsman Cancer Institute to ensure compliance with governing requirements. Huntsman Cancer Institute is committed to cancer prevention, care, and survivorship for all communities within the area we serve – which includes Idaho, Montana, Nevada, Utah, and Wyoming – with impact worldwide. In your cover letter or during your interview process, we invite you to share how your professional experiences have prepared you to serve as a member of our team as we work to reduce the cancer burden experienced by all people and communities. This may include description of your prior experiences related to research, prevention, clinical care, community engagement/outreach, training, administration, or other areas relevant to Huntsman Cancer Institute’s mission and this position. Learn more about the great benefits of working for University of Utah: benefits.utah.edu The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget. Responsibilities Supports all aspects of regulatory compliance. 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 Institutional Review Board (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. Recommends and implements regulatory process improvements. Maintains current knowledge of federal and institutional guidelines and requirements governing research. Maintains regulatory database. Generates ad hoc reports as requested. 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. The incumbent decides how to best accomplish the daily requirements of various regulatory objectives, prioritizes workload and establishes systems needed to achieve specific goals. Efforts of multiple departments or disciplines must be coordinated to ensure effective follow through and compliance of all involved following FDA, Good Clinical Practice, IRB, NIH, and/or other regulatory agency guidelines. Incumbent will be responsible for resolving and/or making appropriate recommendations for correction or full resolution to the Director and other members of the management team. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. Minimum Qualifications EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor’s degree = 4 years of directly related work experience). Department may hire employee at one of the following job levels: Regulatory Affairs Specialist (Life Sciences), II: Requires a bachelor’s (or equivalency) + 4 years or a master’s (or equivalency) + 2 years of directly related work experience. Preferences One year of regulatory experience, an understanding of medical terminology and technical writing experience preferred. Oncology clinical trial experience highly preferred. Working knowledge of Food and Drug Administration (FDA) requirements, Office of Human Research Protection (OHRP), International Conference of Humanization (ICH) Good Clinical Practice (GCP), as well as state and federal guidelines. Knowledge of clinical development process sufficient to effectively direct and manage multiple projects and timelines Strong attention to detail, establishing priorities, and adhering to deadlines Able to show initiative and work independently, take initiative and complete tasks to meet deadlines Excellent interpersonal communication (including oral and written) and leadership skills. Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools SOCRA or ACRP certification Bachelor’s degree in a research or related area plus two years clinical trials/research experience or equivalency; demonstrated human relations and effective communication skills. Type Benefited Staff 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 View phone number on click.appcast.io 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 View phone number on click.appcast.io or View phone number on click.appcast.io or University Human Resource Management at View phone number on click.appcast.io 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 possess a strong commitment to improving access to higher education. 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. Consistent with state and federal law, the University of Utah 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 Title IX (OEO). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at the: University of Utah Non-Discrimination page . Online reports may be submitted at 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. As per University of Utah policy 5-108: Transfer of Benefits Eligible Staff Members , a new hire to the University of Utah who is still serving a 12 month probationary period will not be hired into another University of Utah job (a transfer) until the successful completion of the probationary period. Posting Specific Questions * What is your highest level of completed education? None High School Diploma or Equivalent Associate Degree Bachelor's Degree Master's Degree Doctorate Degree * How many years of related work experience do you have? Less than 2 years 2 years or more, but less than 4 years 4 years or more, but less than 6 years 6 years or more, but less than 8 years 8 years or more, but less than 10 years 10 years or more, but less than 12 years 12 years or more, but less than 14 years 14 years or more Do you have any current relatives working in HCI? (Open Ended Question) Applicant Documents Required Documents Resume Optional Documents Cover Letter Contact Information University Human Resource Management 250 East 200 South, Suite 125 Salt Lake City, UT 84111 Contact us: View phone number on click.appcast.io By Email: View email address on click.appcast.io Security Notice To ensure the security of your data, you will be logged out due to inactivity in 3 minutes at Any data not saved will be lost. Click 'OK' to keep your session active. #J-18808-Ljbffr