Job Information
University of Utah Pediatric Project Manager II in Salt Lake City, Utah
Details
Open Date 09/13/2024
Requisition Number PRN39857B
Job Title Pediatric Project Manager II
Working Title Pediatric Project Manager II
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
Monday through Friday from 8am-5pm.
VP Area U of U Health - Academics
Department 00848 - Pediatric Administration
Location Campus
City Salt Lake City, UT
Type of Recruitment External Posting
Pay Rate Range $58,300-$76,624
Close Date
Priority Review Date
Job Summary
Job Summary
The Utah Data Coordinating Center ( DCC ) has an immediate opening for a Clinical Project Manager II. Come be part of the Utah DCC where we are the expert architects of mission-critical clinical research. This position offers opportunities to work with high functioning, cutting-edge teams that study, understand and improve multi-site research. Bring your background in strong clinical research, protocol development, regulatory and single IRB experience to the Utah DCC . Autonomy, creativity, and critical thinking skills are strongly encouraged. Our clinical project managers manage multicenter clinical trials for both pediatrics and adults, coordinate network consultations, and manage single IRB activities.
As a Clinical Project Manager you are at the center of each research project through working directly with sites, investigators and researchers. The ability to manage local and virtual teams, collaborate with network participants is a must.
In this role, you may support more than one research network and/or research project. Projects include pediatric emergency department trials funded by the PECARN Network (www.pecarn.org), the Network of Pediatric Multiple Sclerosis Centers ( NPMSC ) and the Guthy Jackson Charitable Foundation, a research network addressing Neuromyletis Optica. Our projects also include the NIH funded HEAL (Helping End Addiction Long Term) Pain Management Effectiveness Research Network ( ERN ). You may also support new, exciting, incoming research projects through our business development core.
The Utah DCC offers a career ladder for Clinical Project Managers and provides growth and professional development opportunities.
To learn more about the Utah DCC visithttp://uofuhealth.org/UtahDCC
The University of Utah offers a comprehensive benefits package including:
Excellenthealth care coverageat affordable rates
14.2% retirement contributionsthat vest immediately
Generouspaid leave time
11 paid Holidaysper year
50% tuition reductionfor employee, spouse, and dependent children
Flex spending accounts
Free transiton most UTA services
Employee discounts on a variety of products and services including cell phones & plans, entertainment, health and fitness, restaurants, retail, and travel
Professional development opportunities
Additional benefits information is available atwww.hr.utah.edu/benefits
Responsibilities
Essential Functions:
Independently provides oversight for all aspects of study conduct, regulatory compliance, and record keeping processes at the site or institution level.
Assures regulatory compliance for the data coordinating center
Maintains research data files and regulatory documents for all clinical trial sites.
Identifies and creates queries to improve data capture and assists in developing methods to clarify/clean existing data
Reviews site monitoring reports and discusses findings with Study Investigators and offers suggestions and solutions to problems, concerns, or recurrent trends or themes
Assures that adverse events are reported to the sponsor
Reviews site records for accuracy regarding test article accountability (if applicable)
Develops study specific network guidelines and Standard Operating Procedures
Organizes study trainings and gives presentations to employees and other research coordinators on good clinical practices and study procedure implementation
Acts as liaison between study Investigators and sponsors to communicate and resolve issues
Assumes considerable leadership responsibilities of studies throughout the network
Provides feedback on study site performance, compliance, and data quality
Makes recommendations regarding site disciplinary actions, which may result in site monitoring visits, suspension, or discontinuation of a study site
Performs remote site monitoring activities independently
Licensed professionals may be assigned medical reviews
Must be able to perform the essential functions of a Level 1 Project Manager
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 or DCC Principal Investigator about issues/concerns that arise at the study sites and develops methods to resolve data discrepancies.
Comments
Opportunities for telework may be available if supported by operational needs . Employees with an approved hybrid telework schedule are expected to provide their own home office space, internet connection, telephone, and have the ability to work independently. Certain meetings on campus and conferences may be required to attend in-person. Position may require some travel to project meetings.
This position requires expertise and interpretation of laws, federal regulations, ICH guidelines and Good Clinical Practice guidelines to provide direction/guidance/supervision to study sites. Ensures the sites are compliant with protocol, federal regulations, ICH guidelines, Good Clinical Practice guidelines and local IRB requirements.
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 field, or equivalency (one year of education can be substituted for two years of related work experience). 4 years of clinical research experience that includes project management is also required. Experience with human subjects research, good leadership skills, and working knowledge of FDA , ICH , and other regulatory compliance are also required. Must have excellent interpersonal and communications skills, both oral and written. Must be proficient in Microsoft Office and possess the ability to learn new software programs such as electronic data capture software.
Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), Certified Clinical Research Associate ( CCRA ) or other related certification is highly preferred, along with experience in the specific clinical research area.
Depending on the area of assignment, current medical licensure may be preferred. Licensed professionals must have a current registration or licensure in the State of Utah as required by the profession.
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.
Preferences
Preferences
Experience with human subjects research, excellent communication skills, oral and written. Proficient in Microsoft Office and able to learn new software programs and processes quickly.
Credentialing as a Certified Clinical Research Coordinator ( CCRC ), Certified Clinical Research Professional ( CCRP ), Certified Clinical Research Associate ( CCRA ), or other related certification is highly preferred, along with experience in the specific clinical research area.
Depending on the area of assignment, current medical licensure 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 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 of Utah values candidates who have experience working in settings with students and patients from all backgrounds and possess a strong commitment to improving access to higher education and quality healthcare for historically underrepresented students and patients.
All qualified individuals are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law. Upon request, reasonable accommodations in the application process will be provided to individuals with disabilities.
The University of Utah is an Affirmative Action/Equal Opportunity employer and does not discriminate based upon race, ethnicity, color, religion, national origin, age, disability, sex, sexual orientation, gender, gender identity, gender expression, pregnancy, pregnancy-related conditions, genetic information, or protected veteran’s status. The University does not discriminate on the basis of sex in the education program or activity that it operates, as required by Title IX and 34 CFR part 106. The requirement not to discriminate in education programs or activities extends to admission and employment. Inquiries about the application of Title IX and its regulations may be referred to the Title IX Coordinator, to the Department of Education, Office for Civil Rights, or both.
To request a reasonable accommodation for a disability or if you or someone you know has experienced discrimination or sexual misconduct including sexual harassment, you may contact the Director/Title IX Coordinator in the Office of Equal Opportunity and Affirmative Action ( OEO /AA). More information, including the Director/Title IX Coordinator’s office address, electronic mail address, and telephone number can be located at: https://www.utah.edu/nondiscrimination/
Online reports may be submitted at oeo.utah.edu
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