Clinical Research Analyst II/III/IV - College of Medicine, Office of Research

Classification Title:

Clinical Research Analyst II/III/IV

Classification Minimum Requirements:

Level II: Bachelor’s degree in a relevant field and two years of related experience; or an equivalent combination of education and experience.

Level III: Bachelor’s degree in a relevant field and three years of related experience; or an equivalent combination of education and experience.

Level IV: Master’s degree in an appropriate area and two years of relevant experience; or a Bachelor’s degree in an appropriate area and four years of relevant experience; or an equivalent combination of education and experience.

Job Description:

Are you ready to embark on an exciting journey as a Clinical Research Analyst? Join our team at the Clinical Research Hub (CRH) within the College of Medicine Office of Research! As a Clinical Research Analyst, you'll be at the forefront of cutting-edge research, playing a pivotal role in managing protocols within the Clinical Trials Management System (CTMS), OnCore, for both the Academic Health Center (AHC) and Oncology (ONC) human subject clinical research projects under CRH's purview. You'll be the navigator, ensuring smooth sailing for our study teams by implementing quality checks and institutional guidelines. Collaboration is key as you work alongside CRH members and study teams, driving innovation and excellence. Join us and be part of a team shaping the future of medicine!

The Analyst’s role requires active engagement of study staff to ensure that the research project is accurately represented, and to provide end users with training and development around the management of their studies and subjects in OnCore. The Analyst is responsible for the continued maintenance of assigned projects. Analysts are expected to drive for creative solutions to problems. The Analyst must maintain a high level of professional knowledge and expertise through self-study, independent research, and professional development. The professional knowledge and expertise required includes, but is not limited to proficiency in the OnCore, proficiency in Microsoft Office (Excel, Word, and Outlook), general knowledge of Clinical Trials and Clinical Operations, experience with cancer research protocols, general knowledge of applicable Federal Regulations, and a firm understanding of research workflows and how it aligns with our end customers (Study Teams). The Analyst is responsible for the management of workflow and task list timelines associated within UF’s OnCore.

Level II

Overview: As a Clinical Research Analyst within the Clinical Research Hub at the University of Florida, you will lead critical functions in intake and assessments, portfolio management, customer support and training, and calendar support and budget building. Your expertise will ensure compliance with regulations and guidelines while providing guidance and support to team members and study teams.

Tasks:

1. Intake and Assessments: Complete project intake submission assessments, exercise independent judgment to ensure documentation compliance, and produce Financial Language Assessments (FLAs) for informed consent forms.
2. Portfolio Management: Manage assigned portfolios, maintain protocol records, oversee OCR workflows within the CTMS, and mitigate and/or correct MCA and billing compliance reviews. Act as a liaison between Principal Investigators and agency officials, provide technical assistance during budget and agreement development, and ensure compliance with regulatory requirements.
3. Calendar Support and Budget Build Support: Build protocol calendars and budgets within the CTMS, communicate with study teams for accuracy, and develop procedures to minimize billing risk while facilitating charging.

Level III

Overview: As a Senior Clinical Research Analyst and Team Lead at the University of Florida's Clinical Research Hub, your role encompasses crucial responsibilities in intake and assessments, team portfolio management, customer support and training, and calendar support and budget building. With your expertise, you'll ensure compliance with regulations, efficient management of portfolios, effective customer support and training, and accurate calendar and budget creation. You will help to lead processes, task lists, and team processes.

Tasks:

1. Intake and Assessments: Conduct project intake submission assessments, perform research billing compliance reviews, ensure documentation compliance, and contribute to the development of intake processes and SOP assessments.
2. Portfolio Management: Oversee assigned portfolios, maintain protocol records, manage OCR workflows within the CTMS, provide mentorship and support to team members, and mitigate an