Regulatory Affairs Team Lead

Gainesville, FL - USA

Monthly Salary: $ 68000 - 75000

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Classification Title:	Clinical Research Coordinator III
Classification Minimum Requirements:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Job Description:	The UF Health Cancer Institute 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 all of the University of Floridas 16 colleges pulling together a world-class multi-disciplinary membership of over 350 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 a Regulatory Affairs Team Lead at the UF Health Cancer Institute (UFHCI) you will be responsible for supporting the unit manager in overseeing regulatory compliance operations within the Clinical Research Office. Strong leadership regulatory expertise and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role. In your new role you will be responsible for the following: Overseeing regulatory operations for clinical trial protocols including IRB submissions approvals renewals amendments and regulatory documentation tracking. Leading mentoring and managing regulatory staff including IRB Specialists and Assistants while supporting staff development training and performance management. Providing regulatory guidance to investigators research teams and institutional partners to ensure compliance with federal regulations sponsor requirements and institutional policies. Directing portfolio oversight and quality assurance activities including audit readiness regulatory reporting and clinical trial management system (CTMS) compliance. Developing and implementing standard operating procedures workflow improvements and compliance monitoring strategies to support research excellence and operational efficiency. This is an senior-level position ideal for candidates with experience in clinical research regulatory affairs and human subjects research compliance. 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.
Expected Salary:	$68000 - $75000 This is a TEAMS position and is eligible for a suite of excellent benefits retirement options and paid leave. About the City of Gainesville Home to the University of Florida one of the nations top public universities Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living no state income tax and mild winters. Enjoy the outdoors with over 30 miles of bike trails freshwater springs and numerous water activities plus easy access to beaches and world-class theme parks. Gainesville combines historic charm with modern amenities including a great school system a lively downtown and farmers markets and craft breweries. Discover professional growth and quality of life in Gainesvillewhere community innovation and work-life balance meet! For more information check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds.
Required Qualifications:	Bachelors degree in an appropriate area and three years 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.
Preferred:	N/A
Special Instructions to Applicants:	The 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 is not a remote work position and is located on the University of Floridas Main Campus in Gainesville FL. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	No

Classification Title:Clinical Research Coordinator IIIClassification Minimum Requirements:Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.Job Description:The UF Health Cancer Institute is the 72nd NCI designated...

Classification Title:	Clinical Research Coordinator III
Classification Minimum Requirements:	Bachelors degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Job Description:	The UF Health Cancer Institute 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 all of the University of Floridas 16 colleges pulling together a world-class multi-disciplinary membership of over 350 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 a Regulatory Affairs Team Lead at the UF Health Cancer Institute (UFHCI) you will be responsible for supporting the unit manager in overseeing regulatory compliance operations within the Clinical Research Office. Strong leadership regulatory expertise and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role. In your new role you will be responsible for the following: Overseeing regulatory operations for clinical trial protocols including IRB submissions approvals renewals amendments and regulatory documentation tracking. Leading mentoring and managing regulatory staff including IRB Specialists and Assistants while supporting staff development training and performance management. Providing regulatory guidance to investigators research teams and institutional partners to ensure compliance with federal regulations sponsor requirements and institutional policies. Directing portfolio oversight and quality assurance activities including audit readiness regulatory reporting and clinical trial management system (CTMS) compliance. Developing and implementing standard operating procedures workflow improvements and compliance monitoring strategies to support research excellence and operational efficiency. This is an senior-level position ideal for candidates with experience in clinical research regulatory affairs and human subjects research compliance. 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.
Expected Salary:	$68000 - $75000 This is a TEAMS position and is eligible for a suite of excellent benefits retirement options and paid leave. About the City of Gainesville Home to the University of Florida one of the nations top public universities Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living no state income tax and mild winters. Enjoy the outdoors with over 30 miles of bike trails freshwater springs and numerous water activities plus easy access to beaches and world-class theme parks. Gainesville combines historic charm with modern amenities including a great school system a lively downtown and farmers markets and craft breweries. Discover professional growth and quality of life in Gainesvillewhere community innovation and work-life balance meet! For more information check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds.
Required Qualifications:	Bachelors degree in an appropriate area and three years 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.
Preferred:	N/A
Special Instructions to Applicants:	The 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 is not a remote work position and is located on the University of Floridas Main Campus in Gainesville FL. Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required:	No