Details

　　Open Date 01/18/2024

　　Requisition Number PRN37466B

　　Job Title Regulatory Coordinator, Sr

　　Working Title

　　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 47600 to 90400

　　Close Date

　　Open Until Filled Yes

　　Job Summary

　　The candidate will be responsible for project management support and facilitating the start-up activities of therapeutic oncology-based investigator-initiated trials (IITs) to ensure timely activation. The incumbent will be the administrator of the IPDC to support, coordinate and prepare meeting agendas, minutes, and correspondence. Additional responsibilities include having a strong knowledge of clinical trial regulatory and compliance processes, communicating expectations as they relate to IIT protocol development, and generating reports for IIT activation metrics. Serving as a member in the Research Compliance Office ( RCO ) department, the candidate may also be responsible for quality assurance oversight of clinical trials via monitoring and auditing trials and reporting study progress to the Data Safety Monitoring Committee ( DSMC ). Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position responsibilities.

　　HuntsmanCancer 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. Partnerships with individuals, communities, and many other entities are crucial to our work. Huntsman Cancer Institute values cancer-related health equity, and inclusion as integral to our guiding principle to serve our patients and their communities, and our commitment to foster a culture of belonging for all within our organization.

　　In your cover letter or during your interview process, we invite you to share how your personal and 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 morehere (https://healthcare.utah.edu/huntsmancancerinstitute/about-us/equity-diversity-inclusion)

　　Responsibilities

　　Responsibilities

　　Provide protocol development and implementation support for therapeutic oncology based investigator initiated trials (IITs) conducted at HCI to ensure timelines are met and trials are activated efficiently.Meets with Principal Investigators (PIs) to outline expectations and responsibilities following approval from the Institutional Protocol Development Committee ( IPDC ) for IIT concepts to be developed into a full protocol.Works directly with Principal Investigators (PIs) and study team members to ensure stipulations from approving bodies (scientific review, IRB and radiation safety, FDA Investigational New Drug ( IND )/Investigational Device Exemptions ( IDE ) correspondence) are addressed appropriately and in a timely manner.Provides consultation and assistance to the PI and the study team in completing protocol life cycle requirements.Manages and tracks various teams involved in protocol development, including but not limited to the Research Compliance Office, Clinical Trials Office, and Office of Sponsored Projects to ensure quick turnaround and timely submissions to appropriate parties.Creates timelines in Microsoft Project based on the level of protocol navigation support needed and manages protocol activation logistics.Ensures activities are conducted in a timely manner and in accordance with the HCI policies and guidelines as well as applicable regulatory guidelines.Serves as the point of contact for Protocol Development on IIT projects.Tracks the required approvals necessary prior to study activation.Provide assistance with templating, formatting, editing and addressing questions about oncology clinical trial protocols and informed consent forms ( ICF ) as necessary.Negotiate protocol development timelines as necessary with third party vendors.Maintains up-to date records of workload in task tracking databases.Maintains current knowledge regarding 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.Prepare documents in regard to protocol activation metrics for HCI Senior Leadership to review.Oversees, coordinates, and conducts monitoring of clinical research studies as needed.Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.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.

　　Work Environment and Level of Frequency typically required

　　Nearly Continuously: Office environment.

　　Physical Requirements and Level of Frequency that may be require d

　　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

　　Preferred Qualifications

　　Experience in the management of clinical trials and the clinical development process.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 timelinesStrong attention to detail, establishing priorities, and adhering to deadlinesAble to show initiative and work independently, take initiative and complete tasks to meet deadlinesExcellent 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 toolsSOCRA or ACRP certification preferredType Benefited Staff

　　Special Instructions Summary

　　Additional Information

　　To inquire about this posting, email: [email protected] (%[email protected]) or call 801-581-2300.

　　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 from all backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

　　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:

　　Online reports may be submitted at [email protected]

　　For more information: https://www.utah.edu/nondiscrimination/

　　Online reports may be submitted at oeo.utah.edu

　　For more information: https://www.utah.edu/nondiscrimination/ 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.