Regulatory Coordinator I/II
Regulatory Coordinator I/II
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Job Description
Clinical Research Coordinator I/Clinical Research Assistant
The UF Health Cancer Center is the 72nd NCI designated cancer center and the onlyone at a public university in the State of Florida. As a matrix cancer center we span 12 of the University of Floridas 16 colleges pulling together a world-class multi-disciplinary membership of over 300 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure.
As an entry-levelRegulatory Coordinatorat the UF Health Cancer Center (UFHCC) you will be responsible for managing a portfolio of clinical trials and collaborating with investigators study staff and other key personnel to ensure Sponsor and Institutional Review Board (IRB) to ensure regulatory compliance. Ideal candidates will have some experience or exposure to research and a capacity to understand the complex regulations and policies which govern human subjects research.
In your new role you will be responsible for the following:
- Interpreting the Code of Federal Regulations IRB policies and procedures as well as other regulatory policies regarding human subjects research to best manage your portfolio of clinical trials protocols.
- Coordinating protocol submissions through assigned IRBs and regulatory agencies reviewing documentation to determine appropriate reporting requirements and reporting timeframes preparing IRB submission packets and reviewing with investigators study teams and/or sponsors for accuracy.
- Reviewing documents with investigators and study teams for accuracy noting inconsistencies and inaccuracies as necessary to be corrected within documents and/or the Clinical Trial Management System.
This is an entry-level position ideal for candidates witha strong interest in clinical research public health or healthcare who have experience working in a clinical laboratory or academic research setting such as through internships volunteer work or relevant coursework and are eager to explore regulatory compliance for research.
Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.
Regulatory Coordinator I: $18.00 - $21.00 hourly
Regulatory Coordinator II: $45000 - $52500 annually
This is a TEAMS position and is eligible for a suite ofexcellent benefits retirement options and paid leaveincluding:
- Health Dental and Vision Insurance
- State Retirement Plans
- Paid Time Off (approximately 22 days of vacation leave 13 days of sick leave and 11 paid holidays annually)
- Tuition Assistance (UF Employee Education Program)
- Public Service Loan Forgiveness (PSLF) Eligible Employer
Regulatory Coordinator I: High school diploma or equivalent and one year of relevant experience; or an equivalent combination of education and experience.
Regulatory Coordinator II:Associates degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
Professional clinical research and/or oncology certification (through SOCRA ACRP etc.) are required at the earliest of 12 months from hire or eligibility. Study support and other resources are provided to staff by the department to aid in obtaining required certification(s).
Knowledge/Experience:
Regulatory Coordinator I
- Bachelors degree in one of the basic or social sciences public health or another related field.
- Familiarity with clinical research and/or clinical trials coordination experience is highly desirable.
- Experience working with databases and/or subject data.
- Foundational understanding of research ethics and the responsible conduct of research.
- Foundational understanding of Good Clinical Practice.
Regulatory Coordinator II
- Bachelors degree in one of the basic or social sciences public health or another related field.
- Foundational understanding of clinical research and clinical trials coordination experience is highly desirable.
- Two to three years experience working with databases and/or subject data.
- Working understanding of research ethics and the responsible conduct of research.
- Working understanding of Good Clinical Practice and practical applications in research.
Qualities:
- A highly resourceful team player who can also work independently with professionalism and discretion.
- Strong emotional intelligence with the ability to navigate complex situations and collaborate effectively.
- Excellent time management skills with the ability to prioritize and manage multiple responsibilities with attention to detail.
Skills/Abilities:
- Effective writing and organizational skills.
- Basic project management skills including: delegation scheduling communication critical thinking task and quality management risk management and flexibility.
- Demonstrated ability to manage data accurately and maintain compliance with research protocols.
- Proficiency with the Microsoft Office suite.
University of Florida is a member of the State University System of Florida and an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit.
Applicants must upload a copy of the following documents to be considered for this position:
- Cover Letter or Letter of Interest
- Curriculum Vitae or Resume
- List of Three ProfessionalReferences
This position is eligible for veterans preference. If you are claiming veterans preference please upload a copy of your DD 214 Member Copy 4 with your application for consideration. More information and resources regarding the hiring process including veterans preference can be found here.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
This position has been reposted. Current applicants are still under consideration and need not reapply.
Required Experience:
IC
Employment Type
Full-Time
