University of Utah PS Clinical Site Monitor in Salt Lake City, Utah

Details

Open Date 06/15/2018

Requisition Number PRN17531B

Job Title Clinical Site Monitor

Working Title PS Clinical Site Monitor

Job Grade F

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

Monday – Friday, 8:00 am – 5:00 pm. Occasional weekend and after hours required.

VP Area U of U Health - Academics

Department 01643 - CLINICAL TRIALS OFFICE

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $47,600 - $79,699

Close Date

Open Until Filled Yes

Job Summary

Oversees, coordinates and conducts audits of multiple clinical research projects within the Department of Pediatrics, other University of Utah Departments, and other clinical sites. Provides independent regulatory oversight of all aspects of study conduct at the site, institutional, or network level. Ensures compliance with University policies, Food and Drug Administration (FDA) and Office of Human Research Protection (OHRP) regulations, Good Clinical Practice (GCP), and state and federal guidelines. Independently performs all on-site or remote monitoring activities.

Responsibilities

•Monitors clinical studies in accordance withFDAregulations,ICHguidelines,IRBpolicies, protocol specifications and monitoring plan. Reviews investigational product or device accountability site records for accuracy. Analyzes and documents audit findings and creates monitoring reports.

•Reviews site monitoring reports and discusses findings with clinical trial teams and study Investigators. Provides guidance for appropriately returning the clinical study to full regulatory compliance.

•Works directly with Principal Investigators during protocol development. Provides in-depth review of and suggestions for investigator initiated trial (IIT) protocols. Assists in drafting study monitoring andDSMCplans.

•Works closely with the QA team to develop, monitor, and update quality control systems for tracking compliance activities. Identifies issues, trends, and risk areas. Recommends improvements to operating policies and procedures.

•Develops, coordinates, and participates in educational and training programs to promote compliance and enhance awareness of compliance issues. Conducts in-person training on an individual, department, institutional, and multi-institutional level.

•Teams up with faculty and staff to assist investigators, sites, divisions and departments in implementing compliance practices and monitors and coordinates those activities with the departments.

Minimum Qualifications

Bachelor’s degree in a health science or related field or equivalency; and four years of clinical research experience that includes regulatory compliance monitoring/auditing,IRBapplication submission, and experience in human subjects research. Must have a working knowledge ofFDA,ICH, and other regulatory compliance; an understanding of medical terminology and technical writing experience. Excellent interpersonal communication (including oral and written) and leadership skills also required. Must be proficient in Microsoft Office and possess the ability to learn new software programs.

Preferences include credentialing as a Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), and/or Certified Clinical Research Professional (CCRP). Prior experience as an industryCRAor Monitor is also preferred.

Hiring department may require certification by an appropriate certifying body within two years of hire.

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Preferences

Five years regulatory or clinical trials experience.

Prior experience working with Industry or as a monitor.

Prior experience with Institutional Review Board (IRB) procedures. Ability to write clear and concise reports and present information effectively in various communication settings. Strong interpersonal and customer service skills.

Availability to travel locally and nationally multiple days at a time to initiate and conduct monitoring of national multi-center trials.

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.