Protocol Activation Coordinator II

University of Florida•Gainesville, FL

4d•Onsite

About The Position

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida's 16 colleges, pulling together a world-class, multi-disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure. As a Protocol Activation Coordinator II at the UF Health Cancer Institute (UFHCI), you will be responsible for the coordination of study activation activities in conjunction with investigators, study teams, and CRO administrative staff. In your new role you will be responsible for the following: Building a coverage analysis by working closely with the study team, University of Florida Clinical Research Hub (CRH), and UFHCI leadership to ensure billing compliance for all Clinical Trials at the Cancer Center. Reviewing changes to the schedule of events, OnCore calendar, treatment plan or Medicare Coverage Analysis, updating all as required per protocol amendment. Tracking metrics related to the protocol activation process and reporting back to UFHCI and CRO administration. Completing feasibility questionnaires and facilitating CDA execution and site selection visits, communicating feasibility assessment to representatives of the Disease Site Groups (DSG) and/or Principal Investigator (PI), and making recommendations for changes and alternatives to better execute the protocols. This is a professional level position, ideal for candidates with experience as a clinical research coordinator or in protocol activation and an interest in further developing and specializing in study start-up and management. Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.

Requirements

Bachelor’s degree in Nursing, Basic Sciences, and/or Health Care/Administration.
Demonstrated experience in clinical research coordination/management, including Medicare Coverage Analysis and research compliance.
Experience with clinical research budgeting and negotiation in an academic or medical setting.
Strong analytical, critical thinking, and problem-solving skills with the ability to manage multiple projects and meet deadlines.
Excellent written and verbal communication skills, with the ability to collaborate effectively across internal and external stakeholders.
Proficiency in Microsoft Office and ability to work independently with strong organizational skills.
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Nice To Haves

Three to seven years of experience in study coordination or study management.
Experience with cooperative group trials (e.g., NCTN/ECTCN or other oncology-focused research networks).
Training or experience in project management methodologies (e.g., PMI, Six Sigma, Agile, Scrum).
Resourceful, self-motivated team player with strong professional ethics and discretion.
Forward-thinking with a demonstrated ability to perform in a fast-paced, deadline-driven environment.
Strong interpersonal skills with the ability to build and maintain effective working relationships.
Ability to lead projects, committees, or focus groups through successful completion.
Strong time management skills with the ability to prioritize competing demands and anticipate challenges.
Ability to analyze data, identify issues proactively, and implement effective solutions.

Responsibilities

Coordination of study activation activities in conjunction with investigators, study teams, and CRO administrative staff.
Building a coverage analysis by working closely with the study team, University of Florida Clinical Research Hub (CRH), and UFHCI leadership to ensure billing compliance for all Clinical Trials at the Cancer Center.
Reviewing changes to the schedule of events, OnCore calendar, treatment plan or Medicare Coverage Analysis, updating all as required per protocol amendment.
Tracking metrics related to the protocol activation process and reporting back to UFHCI and CRO administration.
Completing feasibility questionnaires and facilitating CDA execution and site selection visits, communicating feasibility assessment to representatives of the Disease Site Groups (DSG) and/or Principal Investigator (PI), and making recommendations for changes and alternatives to better execute the protocols.