Regulatory Specialist

University Of Florida

Job Location:

Jacksonville, FL - USA

Yearly Salary: $ 55000 - 65000

Posted on: 7 days ago

Vacancies: 1 Vacancy

Job Summary

Classification Title:	Clinical Research Coordinator II
Classification Minimum Requirements:	Bachelors 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) Deans Administration College of MedicineJacksonville 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 activitiesincluding participant screening consent and visit coordinationmay be required as needed.
Expected Salary:	$55000- $65000 per year
Preferred:	* Masters degree or allied health professional degree in an appropriate area. * Minimum of 23 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) which can be found at 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 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Floridas Sunshine Law. This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Health Assessment Required:	Yes

Required Experience:

Classification Title:Clinical Research Coordinator IIClassification Minimum Requirements:Bachelors 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 Rese...

Classification Title:	Clinical Research Coordinator II
Classification Minimum Requirements:	Bachelors 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) Deans Administration College of MedicineJacksonville 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 activitiesincluding participant screening consent and visit coordinationmay be required as needed.
Expected Salary:	$55000- $65000 per year
Preferred:	* Masters degree or allied health professional degree in an appropriate area. * Minimum of 23 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) which can be found at 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 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Floridas Sunshine Law. This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Health Assessment Required:	Yes