Details

Open Date 04/29/2024

Requisition Number PRN38391B

Job Title PS Manager, Clinical Research

Working Title PS Manager, Clinical Research

Job Grade G

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

Full-time, 40 hours per week, Monday – Friday, 8:00 am – 5:00 pm, with occasional evenings and weekends required. Shared on-call responsibilities.

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 $60,700 to $95,000

Close Date

Open Until Filled Yes

Job Summary

The Division of Pediatric Hematology-Oncology in the University of Utah School of Medicine has an immediate opening for a Research Manager. This is an exciting opportunity to oversee the Research Enterprise team of the Division of Hematology/Oncology. This team manages the Children’s Oncology Group ( COG ) clinical trials, the Bone Marrow Transplant and Immunology clinical trials, as well as a myriad of industry/governmental sponsored trials focused on pediatric cancer. Standard of care in the treatment of pediatric cancer is enrollment on a clinical trial, making this team essential in the care of an incredibly special population. Come be part of the team in this vital fight against childhood cancer!

Under minimal supervision, the Clinical Research Manager is responsible for overall management and support, including supervision and evaluation of research support staff.In collaboration with the Principal Investigators and Sr. Research Manager, the incumbent will work to ensure ongoing quality of research efforts throughout the Division of Hematology/Oncology. Responsibilities will include: 1) assisting in planning, organizing, and/or directing all aspects pertaining to research functions, and 2) staffing and management operations pertaining to the research enterprise. Additional specific skills and responsibilities will vary according to the needs of the Division.

The Research Manager will be tasked with developing and implementing a successful strategy to incorporate new studies and consortiums into the current research portfolio. This will include assessment and determination of the support required.

This position will have direct reporting responsibility to the Sr. Research Manager with additional advisory reporting roles to the Children’s Oncology Group site PI, the Pediatric Early Phase Clinical Trial Network PI, the Bone Marrow Transplant and Immunology team PIs, and PIs of other research consortiums in which the division participates.

The University of Utah offers a comprehensive benefits package with excellent health care choices, retirement plans and generous paid leave time. Current benefit information is available athttps://benefits.utah.edu/. Mutual respect and appreciation are highly valued within the Department of Pediatrics.

Responsibilities

• Responsible for the overall day-to-day operations and management of the clinical research functions and staff. This includes Research Coordinators, Regulatory Coordinators and Research Assistants. Responsible for staffing, training, performance tracking and evaluations

• Assign and distribute workload for incoming clinical research studies. Assess priorities of existing studies and new studies and redistributes workload to meet demands for the large number of ongoing trials.

• Assign and supervise the research team across all study activities including pre-, on-going, and post-award project management, monitor enrollment of all studies and participant compliance. Coordinate adherence to regulatory requirements and documentation.

• Supports all aspects of the start-up of the Children’s Oncology Group ( COG ) Pediatric Early Phase Clinical Trial Network ( PEP - CTN ) in the division. This will require flexibility to take on duties (as needed) that span across all disciplines (regulatory, patient coordination, data management) of the research team.

• Supports all aspects of the Bone Marrow Transplant and Immunology research efforts in the division.

• Assess and develop competency of staff through the educational programs and ongoing staff performance evaluations. Maintain coordinator training and compliance with GCP .

• Manage the development and execution of training programs and quality improvement systems, including the development of SOPs, to assure high quality clinical research.

• Organize and ensure proper study startup and closure procedures that conform to institutional requirements. Ensure proper internal and external documentation is maintained, organized, and accessible; projects are managed with adherence to FDA guidance, IRB requirements, and study protocols.

• Study start-up responsibilities include feasibility assessments with internal and external teams, supply procurement, assisting in contract review/negotiation, confirming financial setup, and coordinating external requirements necessary for protocol requirements.

• Develop standard operating procedures and operational infrastructure to ensure that studies are performed with consistent quality across the business unit. Ensure compliance with GCP , HIPAA , IRB , FDA and University policies.

• Schedule, co-chair, and organize weekly research team meetings. Provides reports to PIs and divisional leadership on all active protocols. Provide updates and discuss issues in the weekly staff meetings. Participate in departmental and division research meetings as required.

• Identify budgetary and billing issues and develop solutions. Ensure project adherence to study budget and proper distribution of funds.

• Oversee quality control and compliance of the research team for each active project.

• Recommends and implements overarching process improvements. Create projections regarding research team demand, staffing, and resources.

• Demonstrates initiative, enthusiasm, positive attitude, teamwork, and commitment to the research mission of the department by providing support as needed and where directed.

Comments

This position requires a sophisticated understanding of research standards across all disciplines (i.e. regulatory, patient coordination, data management). The ability to effectively communicate verbally and in writing is also needed with a high level of attention to detail and follow-through.

Work Environment and Level of Frequency typically 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 (one year of education can be substituted for two years of related work experience). 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.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

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

Preferences

• 5 + years of clinic research experience, with experience in study coordination and regulatory operations

• 4+ years of management in the field of research

• Familiarity and/or experience working with the Children’s Oncology Group ( COG )

• Familiarity with oncology clinical trial investigations

• Prior experience managing a large team

• Prior experience managing a variety of research studies including multicenter clinical trials.

• Preference will also be given to candidates with a documented record of working effectively with a wide variety of PI leadership styles while maintaining good research practices.

• Master’s degree in a related area

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.

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

https://safety.utah.edu/safetyreport This report includes statistics about criminal offenses, hate crimes, arrests and referrals for disciplinary action, and Violence Against Women Act offenses. They also provide information about safety and security-related services offered by the University of Utah. A paper copy can be obtained by request at the Department of Public Safety located at 1658 East 500 South.