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

Details

Open Date 03/13/2018

Requisition Number PRN16590B

Job Title Manager, Research

Working Title Manager, Research

Job Grade F

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 01720 - PHS - HEALTH SYS INNO & RSRCH

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range 47600 to 75000

Close Date

Open Until Filled Yes

Job Summary

Independently manages and coordinates research network studies and trials at various clinical sites. Assists in the development of research projects, scientific study design, data interpretation, 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. Licensed professionals may perform medical reviews and analyze or evaluate clinical data.

Responsibilities

1. Independently provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institutional level.

2. Assures regulatory compliance for the data coordinating center.

3. Maintains research data files and regulatory documents for all clinical trial sites.

4. Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data.

5. Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes

6. Assures that adverse events are reported to the sponsor

7. Reviews site records for accuracy regarding test article accountability

8. Develops study specific network guidelines and Standard Operating Procedures

9. Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation

10. Acts as a liaison between study investigators and sponsors to communicate and resolve issues

11. Assumes considerable leadership responsibilities of studies throughout the network

12. Provides feedback on study site performance, compliance, and data quality

13. Makes recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site

14. Performs remote site monitoring activities independently

Disclaimer

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.

Problem Solving

This position makes independent decisions regarding data issues, study procedures and protocol issues as well as recognizing and resolving protocol deviations. It provides input on site performance, compliance and data quality. The position also makes recommendations for disciplinary action, which may result in a site monitoring visit, suspension or discontinuation of a study site. Determines when to involve Study Principal Investigator orDCCPrincipal Investigator about issues/concerns that arise at the study sites and develops methods to resolve data discrepancies.

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.

Minimum Qualifications

Requires a Bachelor’s degree in a related area of assignment or equivalency and 4 – 6 years of progressively more responsible management experience. Background knowledge of assigned 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. Completion of provided supervisory training within one year of employment may be required.

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

Qualified applicants will have excellent interpersonal and communication skills, both oral and written. Must be proficient Microsoft Office and possess the ability to learn new software programs.

Credentialing 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 is highly preferred, along with experience in the specific clinical research area.

Depending on the area of assignment, current medical license may be preferred. Licensed professionals must have a current registration or licensure in the State of Utah as required by the profession.

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.