| 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:
- 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.
- 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 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: Conduct project intake submission assessments, perform research billing compliance reviews, ensure documentation compliance, and contribute to the development of intake processes and SOP assessments.
- Portfolio Management: Oversee 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.
- Customer Support and End User Training: 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.
- Calendar Support and Budget Build Support: Build protocol calendars and budgets within the CTMS, communicate with study teams and fiscal teams for accuracy, ensure compliance with guidelines, minimize billing risk, and troubleshoot calendar and budget-related issues.
Level IV: Lead Clinical Research Analyst / Strategic Operations Manager
Overview: As a Lead Clinical Research Analyst at the Clinical Research Hub (CRH), you serve as a senior subject matter expert and strategic lead for enterprise-wide clinical research operations in the OnCore Clinical Trials Management System (CTMS). You will help to guide institutional policy development and design workflow innovations. This role involves complex problem solving, institutional training oversight, and high-level stakeholder engagement.
Tasks:
- Help to guide enterprise-wide OnCore initiatives, including large-scale configurations, rollouts, and cross-departmental integrations aligned with institutional goals.
- Serve as lead advisor to study teams.
- Represent the CRH in university-wide working groups
- Help to direct the architecture, maintenance, and continuous improvement of workflows and data integrity within OnCore.
- Evaluate and prioritize enhancement requests, develop business cases, and oversee testing, training, and adoption of new OnCore features or modules.
- Mentor and train senior analysts and team leads; guide professional development and quality assurance across all analyst levels.
- Oversee institutional calendar build guidelines and budget methodology for OnCore; resolve escalated financial and billing compliance matters.
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 (11 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 30 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.
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| Preferred: |
The ideal candidate will possess:
Level II:
- 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 III:
- 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.
- Experience using Microsoft Office Applications
Level IV:
- Six 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
- Highly detailed and data driven, 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
- Extensive experience using Microsoft Office Applications
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