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

Details

Open Date 06/14/2018

Requisition Number PRN17502B

Job Title Clinical Site Monitor

Working Title 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

M-F, 8-5

VP Area President

Department 01345 - HCI Clinical Resrch Compliance

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 90400

Close Date

Open Until Filled Yes

Job Summary

The Clinical Site Monitor for Industry Sponsored trials will be responsible for quality assurance management for industry sponsored oncology clinical trials to ensure compliance to the protocol, regulations, guidance and standard operating procedures. Incumbent is responsible for assisting the University in preparation for regulatory audits by developing, monitoring and updating quality controls and recommending actions to maintain compliance. This position is the primary contact and expert regarding regulatory agency standards governing clinical trials. Representative challenges of this position include determining the validity of collected data, assessing process shortfalls, and developing effective safeguards to reduce risk in clinical research. The incumbent must possess the ability to foster collaborative working relationships with a wide range of constituencies.

Responsibilities

1.Oversee, coordinate and conduct quality assurance reviews, on cancer related clinical trials to ensure compliance with study protocol, University, state and federal guidelines.

2.In accordance with the monitoring plan/guidelines developed for each study, conduct source document verification of data submitted by the study sites, ensuring the quality, integrity and validity of the data collected.

3.Conduct drug/device accountability review when applicable.

4.Monitor regulatory documents.

5.Assist study teams in preparation for regulatory audits.

6.Report monitoring findings to the Director of Research Compliance, the Program Manager, and the Principal Investigator as appropriate.

7.Review external clinical research organization (CRO) monitoring visit follow-up reports to ensure adequate follow through and query resolution. This may require interfacing with external industry sponsored monitors.

8.Collaborate with the study team to develop corrective and preventative action plans.

9.Shadow clinical research teams to ensure compliance with the protocol is adhered to as it relates to protocol required test and procedures including but not limited to informed consent and overseeing study visits.

10.Develop, coordinate and participate in educational and training programs to enhance compliance and awareness of regulatory issues.

11.Compile comprehensive reports for Principal Investigators, and other committees as assigned.

12.Analyze and document compliance processes. Recommend process improvements for operating policies and procedures for compliance review. Develop departmental SOPs.

13.Maintain current knowledge regarding federal and state guidance, including Good Clinical Practice (GCP).

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.

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

•Certified Clinical Research Professional (CCRP,CCRCorCCRA)

•Prior experience or knowledge of oncology, and oncology-related research

•Prior experience with Institutional Review Board (IRB) procedures

•Strong written and oral communication skills

•An understanding of University operations, policies and technology is preferred. Training or teaching experience is also preferred.

This position is not responsible for providing patient care.

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

Bachelor’s degree in Health Care Administration, Science, Business Administration or a related field plus five years regulatory or clinical trials experience. Knowledge Federal and International Guidelines (CFRandICH). Proficient with word processing, spreadsheet and related computer applications; demonstrated human relations and effective communication skills also required.

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.