PS Manager Clinical Research

Job Summary
The Division of Pediatric HematologyOncology 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 Childrens 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 Childrens 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 at . Mutual respect and appreciation are highly valued within the Department of Pediatrics.

Responsibilities
Responsible for the overall daytoday 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 ongoing and postaward project management monitor enrollment of all studies and participant compliance. Coordinate adherence to regulatory requirements and documentation. Supports all aspects of the startup of the Childrens 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 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 startup 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 cochair 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 followthrough. 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
Bachelors 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 departments 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. Masters degree in a related area may be preferred. This position is patientsensitive and must fulfill all associated requirements. We protect our patients coworkers and community by requiring all patientsensitive 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.