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.

This position is eligible for university benefits. For the majority of employees, these benefits include:

• Medical-dental-wellness coverage
• A 14.2% of salary employer contribution to the 401(a) retirement plan
• Paid leave
• Paid holidays
• Tuition assistance for employees and family
• Free UTA transport pass

Additional benefits include an environment focused on belonging, wellness, accountability, excellence and transparency and opportunity to harness a growth mindset and contribute to research that could benefit generations to come.

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
• 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
• Assist with monitoring study effort reports, metrics and evaluate workload

Onboarding/Training

• Ensure competency of staff through education programs
• Train coordinators on study-related tasks and documentation
• Ensure training requirements are met for coordination

Other duties and tasks as needed.

Minimum Qualifications

Bachelor's degree in a related area or equivalency. Four to six years of progressively more responsible management experience. Demonstrated leadership skills. Master's degree in a related area may be preferred.

Preferences

Preference will be given to those with ACRP/SOCRA certification. Excellent communication, critical thinking and interpersonal skills. Excellent organization and attention to detail. Ability to work as part of a team and independently. Experience in a healthcare setting or health care certification. Experience with health and research specific electronic data capture systems.