Clinical Research Analyst I - Clinical Research Hub
About The Position
The Clinical Research Analyst I will be a member of the Clinical Trials Support Office within the University of Florida’s (UF) Clinical Research Hub (CRH) . The Analyst will be assisting in building protocols in UF’s Clinical Trials Management System (CTMS) for the Academic Health Center’s (AHC) and the Oncology (ONC) human subject clinical research projects under the purview of CRH. The Analyst is expected to assist with the protocols, provide quality checks, and implement institutional guidelines and procedures. The team member is expected to work collaboratively with other members, as well as study teams. The professional knowledge and expertise required includes but is not limited to proficiency in the CTMS or similar research software, proficiency in Microsoft Office (Excel, Word, and Outlook), general knowledge of Clinical Trials. The Analyst is responsible for the management of workflow and task list timelines assigned within UF’s CTMS. About This Role: Coverage Analysis Support Work on assisting with protocol coverage analyses within the CTMS application and manage requests in a timely and professional manner. Complete Medicare Coverage Analysis (MCA) reviews with other team members. For MCAs acquired from the CTMS vendor, assist team members with validation and completion of the MCA(s) to ensure that they adhere to UF coverage analysis standards. Intake and Assessments Responsible for completing project intake submission assessments, assisting with research billing compliance reviews, and finalizing associated documentation. Review multiple documents related to research projects to ensure adherence to institutional guidelines. Produce Financial Language Assessments (FLAs) for informed consent forms. Portfolio Management Responsible for managing assigned portfolio, maintaining protocol records, building billing grids, and managing OCR workflows within the CTMS and being a navigator with Advarra. Gain proficiency in the CTMS to complete tasks, adjust records and assist UF research units regarding their use of the CTMS. Manage assigned portfolio, maintain protocol records, and oversee OCR workflows within the CTMS. Assist in protocol mitigation or corrections as needed. Customer Support and End User Training Acts as a liaison between Principal Investigator (PI), administrators, agency officials. Interacts closely with PI and their respective staff to provide technical assistance during the development process of clinical research budgets and agreements; and provides guidance to departmental staff, investigators, and research administrators on both sponsor-specific policy and UF requirements. Calendar Support and Budget Build Support Build sponsor pays all AHC and ONC protocol calendars and budgets within the CTMS application. Works to submit, answer queries, and provide quality assurance and feedback for all calendars and budgets built by the vendor. Communicate with study teams, fiscal teams, and coverage analysis staff to ensure accuracy of each calendar. Makes edits as necessary throughout the calendar and budget development process. Other Responsibilities Communicates application defects or workflows issues to CTMS management team, CTMS workgroups, and vendor representatives as appropriate. Assists in testing and validation of the CTMS application during application upgrades and during the implementation of new functionality to ensure proper operation and freedom from defects.
Requirements
- Bachelor's degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Nice To Haves
- 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.
Responsibilities
- Assisting with protocol coverage analyses within the CTMS application and manage requests in a timely and professional manner.
- Complete Medicare Coverage Analysis (MCA) reviews with other team members.
- Assist team members with validation and completion of the MCA(s) to ensure that they adhere to UF coverage analysis standards.
- Completing project intake submission assessments, assisting with research billing compliance reviews, and finalizing associated documentation.
- Review multiple documents related to research projects to ensure adherence to institutional guidelines.
- Produce Financial Language Assessments (FLAs) for informed consent forms.
- Managing assigned portfolio, maintaining protocol records, building billing grids, and managing OCR workflows within the CTMS and being a navigator with Advarra.
- Gain proficiency in the CTMS to complete tasks, adjust records and assist UF research units regarding their use of the CTMS.
- Assist in protocol mitigation or corrections as needed.
- Acts as a liaison between Principal Investigator (PI), administrators, agency officials.
- Interacts closely with PI and their respective staff to provide technical assistance during the development process of clinical research budgets and agreements; and provides guidance to departmental staff, investigators, and research administrators on both sponsor-specific policy and UF requirements.
- Build sponsor pays all AHC and ONC protocol calendars and budgets within the CTMS application.
- Works to submit, answer queries, and provide quality assurance and feedback for all calendars and budgets built by the vendor.
- Communicate with study teams, fiscal teams, and coverage analysis staff to ensure accuracy of each calendar.
- Makes edits as necessary throughout the calendar and budget development process.
- Communicates application defects or workflows issues to CTMS management team, CTMS workgroups, and vendor representatives as appropriate.
- Assists in testing and validation of the CTMS application during application upgrades and during the implementation of new functionality to ensure proper operation and freedom from defects.
Benefits
- Low-cost State Health Plans : Medical, Dental, and Vision Insurance
- Life and Disability Insurance
- Generous Retirement Options to secure your future
- Comprehensive Paid Time Off Packages : (includes over 10 paid holidays, as well as paid family, sick and vacation leave)
- Exceptional Personal and Professional Development Opportunities : Access to UF Training & Organizational Development programs, leadership development, LinkedIn Learning, and more
- Tuition Assistance through the UF Employee Education Program
- Public Service Loan Forgiveness (PSLF) Eligible Employer
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
