PSTO Sr Regulatory Coordinator

Details Open Date 09/04/2024 Requisition Number PRN39752B Job Title Regulatory Coordinator, Sr Working Title PSTO Sr Regulatory Coordinator Job Grade F FLSA Code Administrative Patient Sensitive Job Code? No Standard Hours per Week 40 Full Time or Part Time? Full Time Shift Day Work Schedule Summary VP Area President Department 01345 - HCI Clinical Resrch Compliance Location Campus City Salt Lake City, UT Type of Recruitment External Posting Pay Rate Range 22.88 to 43.46 Close Date Priority Review Date Job Summary Independently utilizes experience and expertise to accurately and efficiently manage the submission of regulatory documents to ensure compliance with governing requirements. Offers mentorship and training to new and junior staff and assists in the development of procedures and policies. Manages complex and non-routine regulatory functions. Responsible for making independent decisions regarding protocol issues and resolving protocol deviations. Preferred Qualifications 2-3 years 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 also required. Proficient in standard Microsoft office applications including Word, PowerPoint, Excel, Project, and other project management tools. SOCRA or ACRP certification. 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. Responsibilities Prepares and ensures submission of appropriate documents to the IRB , including new study applications, continuing reviews, amendments, informed consent, revisions, adverse events, and report forms. Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports. Analyzes and mitigates complex, non-routine regulatory issues and workflow problems. Acts as a liaison between the University parties (PI, regulatory team, study team, etc.) and study sponsors and/or regulatory agencies on all issues pertaining to regulatory compliance. Serves as a resource to the clinical research staff on advanced regulatory issues and concepts. Addresses and resolves complex regulatory matters with industry sponsors and affiliates by defending local policies and upholding compliance. Assists in the development of policies, procedures and process improvements for departmental implementation and guidance for external associates. May act as a lead regulatory team member by managing regulatory work portfolio and assigning tasks to other members of the regulatory team. Provides guidance and training to research faculty and staff pertaining to complex and highly specialized rules and regulations, including complex protocol, multi-site trial and IND / IDE issues. Offers mentorship and training to new and junior staff. Creates educational content to facilitate such training and mentorship. 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 four 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. Three years of regulatory experience, an understanding of medical terminology and technical writing experience required. This position is not responsible for providing patient care. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description. 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.