Regulatory Specialist
Inside Higher Ed, Gainesville, FL, United States
Overview
Job No:
539279
Work Type:
Full Time
Location:
Jacksonville Campus
Categories:
Grant or Research Administration, Health Care Administration/Support
Department:
30010100 - JX-DEAN-ADMINISTRATION
Classification Title:
Clinical Research Coordinator II
Classification Minimum Requirements:
Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Job Description
The Clinical Research Office (CRO) within the Office of Research Affairs (ORA), Dean's Administration, College of Medicine-Jacksonville, is seeking a Clinical Research Coordinator II (Regulatory Focus) with demonstrated experience in clinical trial regulatory management, including industry-sponsored and grant-funded studies. This role is responsible for supporting regulatory operations across multiple clinical trials, with a strong emphasis on study start-up, submissions, and ongoing compliance. The CRC II will lead and coordinate submissions to central and local Institutional Review Boards (IRBs), ensuring all regulatory documents are complete, accurate, and compliant with federal regulations, sponsor requirements, and institutional policies. Key responsibilities include preparation and maintenance of regulatory binders and essential documents, submission of new studies, amendments, continuing reviews, and reportable events, and serving as a primary liaison between sponsors, IRBs, and internal stakeholders. The incumbent will ensure studies remain audit-ready at all times and support monitoring visits, audits, and inspections. The CRC II will collaborate closely with investigators, sponsors, and research teams to facilitate efficient study activation and maintenance. While this role has a regulatory focus, cross-functional support of study coordination activities—including participant screening, consent, and visit coordination—may be required as needed.
Salary
Expected Salary:
$55,000- $65,000 per year
Qualifications
Master's degree or allied health professional degree in an appropriate area.*
Minimum of 2-3 years of regulatory experience in clinical research, including industry-sponsored trial submissions*
Demonstrated experience submitting to and managing studies with central IRBs (e.g., WCG, Advarra) and local IRBs*
Experience supporting both industry-sponsored and grant-funded (investigator-initiated or federally funded) studies*
Proven ability to prepare and manage regulatory documents, including initial submissions, amendments, continuing reviews, safety reports, and study closeouts*
Strong communication skills and ability to prioritize in a fast-paced environment*
Knowledge of HIPAA, Good Clinical Practice (GCP), and research systems such as EPIC, UFIRST, OnCore, REDCap, or similar platforms
Special Instructions To Applicants
This is a time-limited position. Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.
Background Check is Required.
To be considered you must upload your Cover Letter, Resume/CV, and 3 References.
University of Florida College of Medicine - Jacksonville: Visit this link to watch the video.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES).
The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call (352) 392-2HRS or the Florida Relay System at (800) 955-8771 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida’s Sunshine Law.
This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Health Assessment
Health Assessment Required:
Yes
Applications Close
Applications Close:
06 May 2026
To apply
To apply, visit
https://explore.jobs.ufl.edu/en-us/job/539279
Our Commitment
The University of Florida
is an Equal Employment Opportunity Employer. Hiring is contingent on eligibility to work in the U.S. The University of Florida is a public institution and is subject to all requirements under Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call 352-392-2477 or the Florida Relay System at 800-955-8771 (TDD) or visit Accessibility at UF.
Copyright ©2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
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Job No:
539279
Work Type:
Full Time
Location:
Jacksonville Campus
Categories:
Grant or Research Administration, Health Care Administration/Support
Department:
30010100 - JX-DEAN-ADMINISTRATION
Classification Title:
Clinical Research Coordinator II
Classification Minimum Requirements:
Bachelor’s degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Job Description
The Clinical Research Office (CRO) within the Office of Research Affairs (ORA), Dean's Administration, College of Medicine-Jacksonville, is seeking a Clinical Research Coordinator II (Regulatory Focus) with demonstrated experience in clinical trial regulatory management, including industry-sponsored and grant-funded studies. This role is responsible for supporting regulatory operations across multiple clinical trials, with a strong emphasis on study start-up, submissions, and ongoing compliance. The CRC II will lead and coordinate submissions to central and local Institutional Review Boards (IRBs), ensuring all regulatory documents are complete, accurate, and compliant with federal regulations, sponsor requirements, and institutional policies. Key responsibilities include preparation and maintenance of regulatory binders and essential documents, submission of new studies, amendments, continuing reviews, and reportable events, and serving as a primary liaison between sponsors, IRBs, and internal stakeholders. The incumbent will ensure studies remain audit-ready at all times and support monitoring visits, audits, and inspections. The CRC II will collaborate closely with investigators, sponsors, and research teams to facilitate efficient study activation and maintenance. While this role has a regulatory focus, cross-functional support of study coordination activities—including participant screening, consent, and visit coordination—may be required as needed.
Salary
Expected Salary:
$55,000- $65,000 per year
Qualifications
Master's degree or allied health professional degree in an appropriate area.*
Minimum of 2-3 years of regulatory experience in clinical research, including industry-sponsored trial submissions*
Demonstrated experience submitting to and managing studies with central IRBs (e.g., WCG, Advarra) and local IRBs*
Experience supporting both industry-sponsored and grant-funded (investigator-initiated or federally funded) studies*
Proven ability to prepare and manage regulatory documents, including initial submissions, amendments, continuing reviews, safety reports, and study closeouts*
Strong communication skills and ability to prioritize in a fast-paced environment*
Knowledge of HIPAA, Good Clinical Practice (GCP), and research systems such as EPIC, UFIRST, OnCore, REDCap, or similar platforms
Special Instructions To Applicants
This is a time-limited position. Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.
Background Check is Required.
To be considered you must upload your Cover Letter, Resume/CV, and 3 References.
University of Florida College of Medicine - Jacksonville: Visit this link to watch the video.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES).
The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call (352) 392-2HRS or the Florida Relay System at (800) 955-8771 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida’s Sunshine Law.
This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Health Assessment
Health Assessment Required:
Yes
Applications Close
Applications Close:
06 May 2026
To apply
To apply, visit
https://explore.jobs.ufl.edu/en-us/job/539279
Our Commitment
The University of Florida
is an Equal Employment Opportunity Employer. Hiring is contingent on eligibility to work in the U.S. The University of Florida is a public institution and is subject to all requirements under Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call 352-392-2477 or the Florida Relay System at 800-955-8771 (TDD) or visit Accessibility at UF.
Copyright ©2025 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency
jeid-7c2889a2c7753a4bab88ee1b68611289
#J-18808-Ljbffr