Job Summary

We are excited to bring in a new member to our Population Sciences Research Infrastructure Systems and Management Population Sciences Trials Office and Adapt team! Our PRISM PSTO/Adapt staff are involved in research studies associated with population sciences based research at Huntsman Cancer Institute. If you are passionate about contributing to HCI's vision of delivering a cancer free frontier by developing and leading studies, this is the role for you!

The new member will be responsible for managing research projects and staff. The program manager will support principal investigators and staff through the project life cycle from start to end. This work may include supporting investigator-initiated studies and sponsored projects.

Responsibilities

Administration

• Serve as liaison/point of contact between study sponsor, investigators, study coordinators as well as regulatory or finance where applicable
• Participate in Canvas Update Working Group for the implementation and oversight of the training program and platform
• Provide feedback on policies and procedures for investigator services, staff management and budgetary goals/objectives
• Market and promote PSTO/Adapt services
• Facilitate relationships with the community and across the University of Utah and Huntsman Cancer Institute
• Develop strategies for continuous quality improvement
• Project management duties and tasks for PSTO/Adapt studies
• Organize UBox
• Represent the research program at meetings, national and international research consortia.
• Correspond with appropriate parties to execute agreements (CTA's, CDA's, DTA's, etc.).
• Assist in development and implementing strategic initiatives for PSTO/Adapt.
• May be assigned other duties as needed based on department need.

Study Operations

• Manage overall research studies from start-up to completion.
• Coordinate program activities across multiple studies.
• Foster collaboration and communication, ensure investigator satisfaction
• Evaluate the needs of each site for studies
• Coordinate Oncore setup with regulatory and finance personnel
• Develop work practice documents and review standard operating procedures
• Build study templates
• Ensure adherence to ICH Guidelines, Code of Federal Regulations and Standard Operating Procedures.
• Attend study meetings
• Update Ubox folders for studies as needed and moves studies to completed' status when applicable.
• Create fast facts' sheets and checklists
• Provide back-up for study team
• Update investigators on study progress.
• Primary contact with the data personnel and coordinate data build.
• Coordinating PACS access for staff when needed

Finance

• Allocate resources effectively within programs.
• Frequently meet with finance teams for study invoicing
• Review and provide input on study budgets to completion
• Primary contact with finance team.

Regulatory

• Supervise coordination compliance across studies
• Primary contact with regulatory.
• Address regulatory issues.
• Implement best practices.
• Create and/or review study documents, except the informed consent, for IRB submissions
• Document amendment changes needed for ERICA.
• Gather and review study documents for IRB approval

Supervision

• Report to PSTO/Adapt Clinical Research Manager
• Provide guidance and support to study coordinators and clinical research coordinators.
• Supervise PSTO and ADAPT study and clinical research coordinators but not limited to the following: Assist in interviews, Performance management, 1:1's, Kronos, Time off approval, Complete annual reviews and probationary meetings as needed, Provide training, mentorship and guidance to study coordinators and clinical research coordinators to ensure comprehensive completion and compliance with their job responsibilities.
• Assist with monitoring study effort reports, metrics and evaluate workload for and research staff bandwidth for individuals listed above.

Onboarding/Training

• Ensure competency of staff through education programs and informing clinical research manager of any performance management concerns
• Include clinical research manager on all performance concerns and escalate for the clinical research manager to address after second occurrence.
• Train coordinators on study-related tasks and documentation
• Ensure training requirements are met for coordination.

Other duties and tasks as needed.