University of Utah Regulatory Coordinator in Salt Lake City, Utah
Open Date 05/31/2017
Requisition Number PRN14344B
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
Work Schedule Summary
Monday – Friday
8:00 a.m. to 5:00 p.m.
VP Area Health Sciences
Department 01643 - CLINICAL TRIALS OFFICE
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $39,300 to $64,349 DOE
NOTE: May close at anytime.
Open Until Filled
NOTE: May close at anytime. Yes
Develops and coordinates the submission of regulatory documents to ensure compliance with all governing requirements. Supports the Principal Investigator and study team(s) ensuring compliance with all University, state and federal regulations that govern clinical research. Prepares applicable submission forms and submits updated documents to theIRBincluding but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, FormFDA1572s and informed consent documents. Maintains and accurately files all necessary logs within the regulatory binder(s). Detailed knowledge of human subject research regulations, strong demonstrated attention to detail and the ability to adhere to policies and procedures. Maintains all regulatory files for each trial assigned by maintaining accurate filing and recording of regulatory information.
•Supports all aspects of regulatory compliance. Prepares, facilitates, submits and maintains the process for accurate and timely submission ofIRBapplications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies forIRBapproved protocols as required by the federal regulations and internal policy.
•Facilitates and coordinates all aspects ofIRBsubmissions. Includes evaluating the 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.
•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 theIRB.
•Submits study renewal applications and study progress reports to theIRB.
•Coordinates with study sponsor, investigator andIRBto 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.
This position utilizes federal,ICH/GCPand 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.
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.
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.
Understanding and experience in reporting procedures for serious adverse events (SAEs) to sponsors, Institutional Review Boards (IRBs) and theFDA. Demonstrated knowledge and experience preparingIRBsubmissions, sponsor communications, andFDA-required forms preferred. Demonstrated knowledge and experience with regulatory procedures,HIPAAcompliance, and Federal and local regulations for research on human subjects.
Type Benefited Staff
Special Instructions Summary
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: firstname.lastname@example.org 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: email@example.com .
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.