University of Utah Regulatory Coordinator in Salt Lake City, Utah

Details

Open Date 06/14/2017

Requisition Number PRN14487B

Job Title Regulatory Coordinator

Working Title Regulatory Coordinator

Job Grade E

FLSA Code Administrative

Patient Care Job Code? No

Standard Hours per Week 40 hrs/wk

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday, business hours with occasional evenings and weekends. Shared on-call responsibilities.

VP Area Health Sciences

Department 00852 - Pediatric Emergency Medicine

Location Other

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $39,300 to $56,000 DOE

Close Date

NOTE: May close at anytime.

Open Until Filled

NOTE: May close at anytime. Yes

Job Summary

The Regulatory Coordinator provides clinical and administrative support to the Division of Pediatric Emergency Medicine (DoPEM) for research activities within the research enterprise. The incumbent will organize, coordinate, and oversee regulatory, compliance, clinical and administrative details of research activities for multiple projects while achieving the project objectives and maintaining the integrity and compliance to a host of department, university, and federal rules and regulations.

Responsibilities

•Prepares and submits all initial, renewal, and study closure reports to theIRB,OSPand any other regulatory agencies.

•Tracks study approvals, updates, and expirations to ensure uninterrupted project progress.

•Tracks sponsor and PI-initiated amendments, submits amended protocols, summaries, and consents to theIRB.

•In conjunction with PI, ensures that the rights and welfare of research participants are protected in accordance with federal and institutional guidelines.

•Completes, audits, and maintains study records, materials, and databases to ensure compliance with study protocols,FDA,IRB, departmental, and university regulations.

•Tracks adverse events. Reports serious adverse events and protocol violations toIRBand sponsor.

•Assists PIs and other research staff with research process and policy issues, also provides regulatory process guidance and teaching.

•Assists with preparation of grant applications and management of awarded contracts. Works withOSPandGCAto oversee budgetary expenses.

•Maintains current knowledge of federal and institutional guidelines and requirements governing research.

•Maintains division-specific regulatory binders and tracking database.

•Recommends and implements regulatory process improvements to managers, PIs, and other study personnel.

Clinical Research Coordinator

•Coordinates research projects and activities. Oversees day-to-day clinical research to guarantee the effective follow-through of study protocols and identified goals.

•Collaborates with the project PIs to identify research project goals, assess protocol for clarity and subject safety, review inclusion/exclusion criteria, and then designs a system to accomplish these goals within study time frame and budget constraints.

•Supports preparatory study activities by designing site workflow and study training programs.

•Meets often with PIs, managers, and other research personnel to update overall study progress and make modifications as needed.

•Designs documents, devices, tools, and educational programs and systems to ensure proper patient capture and facilitate accurate data collection.

•Ensures the quantity and quality of data meets specific project objectives. Maintains validity and verifies accuracy of data.

•Obtains informed consent, medical history and demographics; documents and maintains historical data, status reports, progress notes, and subject logs.

•Participates in shared on-call responsibilities for enrolling study patients in the ED.

•Assists in training, oversight and mentoring of research assistants. Assists in developing and documenting research education programs for clinical staff.

•Pursues additional research education opportunities by attending Research Administration Training Series.

•Performs other necessary research support functions as assigned by PI, manager, clinical research coordinator, or division chief.

Team Player

•Attends and participates in division Career Development meetings.

Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of DoPEM and the department by providing assistance and support as needed and where directed.

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 not responsible for providing patient care.

Preferences

•Experience withIRBand other regulatory processes, protocols, procedures, data collection, etc.

•Regulatory and administrative experience organizing and coordinating multiple research projects running simultaneously

•Basic understanding of emergency medicine clinical practices and medical terminology

•The ability to effectively communicate and work with research regulatory agencies, research subjects, and personnel at all levels

•Working knowledge of research software programs and large databases

•IRBCITICourse in the Protection of Human Research Subjects certificate required;CCRCcertification or equivalent preferred. Must have after one year of employment

Applicants will be screened according to preferences.

Type Benefited Staff

Special Instructions Summary

Additional Information

The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.

To inquire about this posting, email: employment@utah.edu or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: oeo@umail.utah.edu .

The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.

This position may require the successful completion of a criminal background check and/or drug screen.