Regulatory Coordinator I

Clinical Research Assistant

As a Regulatory Coordinator I at 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 with an interest in establishing careers in clinical research and an interest in exploring 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.

$18 - $21 hourly; Commensurate with education and experience.

This is a TEAMS position, and is eligible for a suite of excellent benefits, retirement options, and paid leave.

High school diploma or equivalent and one year of relevant experience; or an equivalent combination of education and experience.

Knowledge/Experience:

• Bachelor’s Degree in Basic Sciences and/or Health Care and two to three years of research experience and/or training in an Academic Medical Center preferred.
• Experience working with databases and/or subject data.
• Foundational understanding of research ethics and the responsible conduct of research, with a focus on the regulations and guidelines governing human subject clinical trials.
• Clinical research/trials coordination experience is highly desirable, as well as foundational understanding of oncological and clinical research concepts and terminology.
• Foundational understanding of Good Clinical Practice.

Qualities:

• Strong interpersonal skills, as well as the ability to work with a broad range of people including investigators, physicians, clinic and hospital staff, sponsors, partners at other institutions, UFHCC staff, and others.
• Highly resourceful team-player, with the ability to also be extremely effective, independent, interact professionally, and utilize effective writing and organizational skills.
• Demonstrate understanding and effective use of Emotional Intelligence strategies and skills.

Skills/Abilities:

• Demonstrated ability to establish and maintain effective working relationships with stakeholders and critical staff, both internally and externally, through a variety of communication mediums and venues.
• Basic project management skills including: delegation, scheduling, communication, critical thinking, task and quality management, risk management, and flexibility.
• Proven ability to handle confidential information with discretion, be adaptable to various competing demands, and demonstrate the highest level of customer/client service and response.
• Proficiency with the Microsoft Office suite.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information, and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

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 Professional References

Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

This position is eligible for veteran’s preference. If you are claiming veteran’s preference, please upload a copy of your DD 214 Member Copy 4 with your application for consideration. See our Veteran's Preference Page for more specific information.