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University of Utah Manager, Clinical Research in Salt Lake City, Utah

Details

Open Date 05/08/2019

Requisition Number PRN20634B

Job Title Manager, Clinical Research

Working Title Manager, Clinical Research

Job Grade G

FLSA Code Administrative

Patient Sensitive Job Code? No

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

VP Area U of U Health - Academics

Department 00952 - Division of Epidemiology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 60700 to 101649

Close Date

Open Until Filled Yes

Job Summary

Under minimal supervision, manages and coordinates complex multi-million-dollar network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, protocol development, data interpretation and analysis, training of research site personnel, and maintains regulatory compliance, patient safety, and data quality. Monitors the conduct and progress of studies to ensure compliance with established protocols and study timelines. Provides mentoring and leadership for junior team members. Acts as a catalyst between the program and its customers and staff to ensure continuity and quality of service and care.

This position is housed in Internal Medicine, Epidemiology for thePARCKAprogram.PARCKAis the Program for Addiction Research, Clinical Care, Knowledge and Advocacy. Our mission is to promote and provide addiction related research, clinical care, knowledge and advocacy across the University of Utah, the local community, the state, and the nation. Website: https://medicine.utah.edu/internalmedicine/epidemiology/parcka/

Preference may be given to those credentialed as a Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Project Management Professional (PMP), or other related certification, and clinical research experience that includes project management.

Knowledge ofFDA,ICH, and other regulatory guidelines, experience in writing research materials as well as excellent interpersonal and communication skills. Proficiency in Microsoft Office and the ability to learn new software programs is also required.

Responsibilities

1.Assists network clinical investigators and research staff with the development of scientific research projects and oversees protocol development

2.Works with investigators to design data collection tools and other data elements

3.Prepares, submits, and maintains regulatory documents and research correspondence

4.Leads and mentors junior team members

5.Forecasts, develops and implements policies and procedures in the areas of customer service, staffing and budgetary goals and objectives that are consistent with University of Utah’s policies

6.Markets and promotes new and existing programs and services to internal and external customers

7.Participates in University-wide committees to establish customer service standards and administrative plans and policies

8.Facilitates cooperative and collaborative community and institutional relationships

9.Ensures customer satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through

10.Develops departmental strategies consistent with the assigned departments continuous quality improvement program

Comments

This position requires expertise and interpretation of laws, federal regulations,ICHguidelines and Good Clinical Practice guidelines to provide direction/guidance/supervision to study sites. Ensures the sites are compliant with protocol, federal regulations,ICHguidelines, Good Clinical Practice guidelines and localIRBrequirements.

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.

Work Environment and Level of Frequency that may be 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.

Minimum Qualifications

Bachelor’s degree in a related area or equivalency (2 years related work experience may be substituted for 1 year of education). Four to six years of progressively more responsible management experience. Background knowledge of hiring department’s area of specialization in order to analyze, plan and draw conclusions for recommendations to superiors. Demonstrated leadership skills in planning and directing employees and processes in order to effectively monitor and develop subordinates and to ensure the smooth operation of department. Master’s degree in a related area may be preferred.

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

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”). 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. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.

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

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with priorURSservice, may elect to enroll inURSif 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 fromURSare subject to URS’ post-retirement rules and restrictions. Please contact Utah Retirement Systems at (801) 366-7770 or (800) 695-4877 or University Human Resource Management at (801) 581-7447 if you have questions regarding the post-retirement rules.This position may require the successful completion of a criminal background check and/or drug screen.

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