Clinical Research Analyst I - Clinical Research Hub

University of Florida • Gainesville, FL

11h • Onsite

About The Position

The University of Florida’s Clinical Research Hub is seeking a Clinical Research Analyst I to join their team and support impactful clinical research initiatives. The Clinical Research Analyst 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 responsible for 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 assisting with task list timelines assigned within UF’s CTMS.

Requirements

• Bachelor's degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
• Proficiency in the CTMS or similar research software
• Proficiency in Microsoft Office (Excel, Word, and Outlook)
• General knowledge of Clinical Trials

Nice To Haves

• One year of experience in business administration and/or financial management in an professional 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

• Responsible for completing project intake submission assessments, assisting with research billing grid reviews, and finalizing associated documentation
• Review multiple documents related to research projects to ensure adherence to institutional guidelines
• Review Cost Language Template selections for informed consent forms
• Responsible for managing assigned portfolio, maintaining protocol records, building billing grids, and managing CRH 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 CRH workflows within 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
• Provides guidance to departmental staff, investigators, and research administrators on both sponsor-specific policy and UF requirements
• Build sponsor pays all AHC 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
• Communicates 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
• 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

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 with 10+ paid holidays, paid family, sick and vacation leave
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level