Regulatory Coordinator

Details

Open Date 06/22/2022

Requisition Number PRN31107B

Job Title PS Regulatory Coordinator

Working Title 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, 40 hours per week, Monday – Friday, 8:00 am – 5:00 pm with occasional evenings and weekends required. Shared on-call responsibilities.

VP Area U of U Health - Academics

Department 00857 - Pediatric Hematology/Oncology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $39,300 to $64,349

Close Date

Open Until Filled Yes

Job Summary

Job Summary

The Division of Pediatric Hematology-Oncology in the University of Utah School of Medicine has an immediate opening for a Regulatory Coordinator. This is an exciting opportunity to join our Bone Marrow Transplant and Immunology research team. This team will work on various consortium (Primary Immune Deficiency Treatment Consortium, Center for International Blood and Marrow Transplant Research, Children’s Oncology Group) sponsored clinical trials as well as a myriad of industry/governmental sponsored trials. Come be part of the team to help in the fight against childhood cancer and other nonmalignant disorders.

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.

The University of Utah offers a comprehensive benefits package including:

• Excellenthealth care coverage (https://www.hr.utah.edu/forms/lib/SummaryComparisonEmployeeHCP.pdf) at affordable rates


• 14.2% retirement contributions (https://www.hr.utah.edu/benefits/retire\_401aPlan.php) that vest immediately


• Generouspaid leave time (https://www.hr.utah.edu/benefits/paidLeave.php)


• 10 paid Holidays per year


• 50% tuition reduction (https://www.hr.utah.edu/benefits/tuition.php) for employee, spouse, and dependent children


• Flex spending accounts (https://www.hr.utah.edu/benefits/fsa.php)


• 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 www.hr.utah.edu/benefits

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.


• 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 Hem/Onc and the department by providing assistance and 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 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 of Utah values candidates who have experience working in settings with students from diverse backgrounds and possess a strong commitment to improving access to higher education for historically underrepresented students.

Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities and protected veterans are 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:

Director/ Title IX Coordinator

Office of Equal Opportunity and Affirmative Action ( OEO /AA)

135 Park Building

Salt Lake City, UT 84112

801-581-8365

[email protected]

Online reports may be submitted at oeo.utah.edu

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

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.