Title: PS Regulatory Coordinator

Location: Salt Lake City United States

Job Description:

Requisition Number: PRN40877B

Job Title: PS Regulatory Coordinator

Job GradeE

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, Monday – Friday, 8:00 am – 5:00 pm with occasional evenings and weekends required. Opportunities for a hybrid telework schedule may be available if supported by operational needs. Employees with an approved hybrid telework schedule are expected to provide their own home office space, internet connection, telephone, and have the ability to work independently.

VP AreaU of U Health - Academics

Department00848 - Pediatric Administration

LocationCampus

CitySalt Lake City, UT

Type of RecruitmentExternal Posting

Pay Rate Range$39,300 to $68,349

Priority Review Date (Note - Posting may close at any time)

Job Summary

The Division of Pediatric Cardiology at the University of Utah Spencer Fox School of Medicine has an immediate opening for a Regulatory Coordinator. This is an exciting opportunity to be a part of the Research Enterprise team of the Division of Cardiology. This position supports a myriad of consortium and industry/governmental sponsored trials focused on pediatric congenital and acquired heart disease.

Develops and coordinates the submission of regulatory documents to ensure compliance with 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:

Excellent health care coverage at affordable rates
14.2% retirement contributions that vest immediately
Generous paid leave time
11 paid Holidays per year
50% tuition reduction for employee, spouse, and dependent children
Flex spending accounts
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

This position will report directly to the Administrative Director of the Heart Center Research Enterprise.

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.
Assists in aiding trial activation across disciplines as needed.
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 the department by providing support as needed and where directed.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

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 (one year of education can be substituted for two years of related work experience) 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

TypeBenefited 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. 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).

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