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

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's 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.

They are responsible for maintaining assigned projects and are expected to seek 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).

Level I Overview : As the Clinical Research Analyst, your primary responsibility is to ensure the smooth intake and assessment process for clinical research projects while maintaining compliance with institutional guidelines.

Additionally, you will assist with managing assigned portfolios, providing support in protocol management and OCR workflows within the CTMS. Tasks :

• Intake and Assessments : Complete project intake submission assessments, assist with research billing reviews, and finalize associated documentation, including Financial Language Assessments(FLAs) for informed consent forms.
• Portfolio Management : Manage assigned portfolio, maintain protocol records, and oversee OCR workflows within the CTMS, gaining proficiency to assist UF research units and provide protocol mitigation or corrections as needed.
• Calendar Support and Budget Build Support : Build sponsor pays all AHC and ONC protocol calendars and budgets within the CTMS application.

Communicate with study teams, fiscal teams, and coverage analysis staff to ensure accuracy and minimize billing risk.

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 :

• Intake and Assessments : Complete project intake submission assessments, perform research billing compliance reviews, exercise independent judgment to ensure documentation compliance, and produce Financial Language Assessments (FLAs) for informed consent forms.
• 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.

Calendar Support and Budget Build Support : Build protocol calendars and budgets within the CTMS, communicate with study teams, fiscal teams, and coverage analysis staff 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 :

Intake and Assessments : Completing project intake submission assessments, perform research billing compliance reviews, exercise independent judgment to ensure documentation compliance, and produce Financial Language Assessments (FLAs) for informed consent forms.

Contribute to the development of intake processes and SOP assessments.

Portfolio Management : Lead in managing assigned portfolios, maintain protocol records, manage OCR workflows within the CTMS, provide mentorship and support to team members, and mitigate and correct MCA and billing compliance reviews.

Act as a liaison between Principal Investigators, administrators, and agency officials, troubleshoot problems, review billing plans and amendments, provide technical assistance, and facilitate end-user training and documentation development.

Manages task assignments amongst the team and ensures compliance with established guidelines and procedures.

Calendar Support and Budget Build Support : Build protocol calendars and budgets within the CTMS. Communicate with study teams, fiscal teams, and coverage analysis staff for accuracy, ensure compliance with guidelines, minimize billing risk, and troubleshoot calendar and budget-related issues.

We Offer Exceptional Benefits

• Low-cost State Health Plans : Medical, Dental, and Vision Insurance
• Life and Disability Insurance
• Florida Retirement System Retirement Plans
• Paid Time Off ( paid holidays, in addition to paid family, sick and vacation leave)
• Personal and Professional Development Opportunities (UF Training & Organization Development, LinkedIn Learning)
• Tuition Assistance (UF Employee Education Program)
• Public Service Loan Forgiveness (PSLF) Eligible Employer

The City of Gainesville

Discover Gainesville, Florida, home to the University of Florida College of Medicine, where modern attractions and natural beauty harmonize to create an exceptional living environment.

Enjoy a low cost of living, no state income tax, outstanding public and private schools, and pleasant winters in a community that passionately supports Division I NCAA sports (Go Gators!).

Explore scenic bike trails, lively farmer's markets, and a thriving local brewery scene. Immerse yourself in over miles of biking and hiking trails, encounter diverse wildlife in Florida State Parks, and experience thrilling adventures in freshwater springs.

Gainesville's central location offers easy access to both the Gulf of Mexico and the Atlantic Ocean, providing stunning beaches, nature preserves, and world-renowned theme parks within a day's drive.

Become part of our vibrant community, where the perfect blend of opportunities awaits.

Expected Salary : Level I : $, - $,

Level I : $, - $,

Level II : $, - $,

Level III : $, - $,

Minimum Requirements :

Level I : Bachelor’s degree in a relevant field and one year of related experience; or an equivalent combination of education and experience.

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.

Preferred Qualifications :

The ideal candidate will possess :

Level I

• One year of experience in clinical research administration and / or financial management in an academic / medical setting.
• Familiarity with the OnCore CTMS by Advarra or similar clinical trial management software.
• Ability to balance customer service and research compliance.
• Ability to organize and work effectively, prioritize, be flexible, and stay on task in a high-paced, high-volume professional environment.
• Skilled in problem solving techniques, critical thinking, and creativity.
• Strong time management, organizational, documentation, attention to detail, and task follow up skills.
• Experience using Microsoft Office Applications.

Level 2

• Two years or more of experience in clinical research administration and / or financial management in an academic / medical setting.
• Familiarity with the OnCore CTMS by Advarra.
• Experience building calendars and budgets in the OnCore CTMS by Advarra.
• Experience training OnCore functionality and in subject management.
• Ability to work with detailed data and information, understand various reporting / tracking tools, and interpret and apply the data and information.
• Ability to balance customer service and research compliance.
• Ability to independently and collaboratively organize and work effectively, prioritize, be flexible, and stay on task in a high-paced, high-volume professional environment.
• Ability to develop and maintain effective working relationships in a diverse and multilayered team environment.
• Skilled in problem solving techniques, critical thinking, and creativity, and possess aptitude to develop new solutions.
• Experience using Microsoft Office Applications.

Level 3

• Four years or more of experience in clinical research administration and / or financial management in an academic / medical setting.
• Extensive familiarity with the OnCore CTMS by Advarra.
• Advanced experience building calendars and budgets in the OnCore CTMS by Advarra.
• Experience training OnCore functionality and in subject management.
• Ability to work with detailed data and information, understand various reporting / tracking tools, and interpret and apply the data and information.
• Ability to balance customer service and research compliance.
• Ability to independently and collaboratively organize and work effectively, prioritize, be flexible, and stay on task in a high-paced, high-volume professional environment.
• Extremely strong oral and written communication skills.
• Ability to analyze complex situations, identify workable solutions / alternatives, and make appropriate recommendations that consider the competing needs and priorities of various stakeholders.
• Ability to develop and maintain effective working relationships in a diverse and multilayered team environment.
• Skilled in problem solving techniques, critical thinking, and creativity, and possess aptitude to develop new solutions.
• Ability to assess, assist, confirm, educate, and monitor user expectations and satisfaction.
• Strong time management, organizational, documentation, attention to detail, and task follow up skills.
• Experience using Microsoft Office Applications.
10 days ago