Details

Open Date 03/12/2024

Requisition Number PRN37937B

Job Title Regulatory Coordinator, Sr

Working Title Regulatory Coordinator, Sr

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

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. Responsibilities include having a strong knowledge of clinical trial regulatory and compliance processes, communicating expectations as they relate to IIT protocol development with numerous relevant stakeholders, 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 providing quality assurance oversight of clinical trials via monitoring and auditing trial progress in the event of an FDA inspection. Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position responsibilities. This is a hybrid position requiring in-person and remote work.

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

Responsibilities

• Provide project management support for investigator-initiated trials (IITs) conducted at HCI to ensure timelines are met and trials are activated efficiently.

• Prepares and ensures submission of appropriate documents to the IRB prior to study activation.

• Prepares and facilitates advanced regulatory submissions, including IND and/or IDE applications and reports to the FDA . This includes Expanded Access Single Patient IND requests.

• 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.

• Drafts, formats, and edits informed consent forms (ICFs).

• Works directly with Principal Investigators (PIs) and study team members to ensure stipulations from approving bodies are addressed appropriately and in a timely manner.

• Provides consultation and assistance to the PI and the study team on the process for trial activation at HCI .

• Manages and tracks timelines across various teams that are working in tandem during the protocol development process to ensure all parties are ready to activate a new IIT .

• In collaboration with the Protocol Writing team, serves as the point of contact for Protocol Development on IIT projects.

• Tracks the required approvals necessary prior to study activation.

• 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 regarding protocol activation metrics for HCI Senior Leadership.

• Recommends enhancements to standard operating policies and procedures for compliance review. Develop departmental SOPs.

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, the clinical development process and associated regulations.

• Oncology clinical trial experience highly preferred.

• 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, work independently, 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, and Excel.

• SOCRA or ACRP certification preferred.

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.