Current jobs related to Clinical Research Regulatory Specialist II - Gainesville, Florida - University of Florida
-
Clinical Research Associate
2 weeks ago
Gainesville, Florida, United States Exactech Full timeJob OverviewExactech is seeking a highly skilled Clinical Research Associate to join our team. As a key member of our clinical research team, you will be responsible for overseeing assigned clinical research projects to ensure high-quality data is obtained to support regulatory and marketing needs.Key ResponsibilitiesMonitor the progress of clinical studies...
-
Clinical Research Coordinator
2 weeks ago
Gainesville, Florida, United States InsideHigherEd Full timeJob Title: Clinical Research CoordinatorWe are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at the UF Norman Fixel Institute for Neurological Diseases.Key Responsibilities:Coordinate clinical care, research studies, and regulatory management for multidisciplinary clinics focused on Atypical Parkinson disorders...
-
Clinical Research Coordinator
2 weeks ago
Gainesville, Florida, United States North Florida Foundation for Research and Education Inc Full timeJob SummaryWe are seeking a highly skilled Clinical Research Coordinator to join our team at North Florida Foundation for Research and Education Inc. The successful candidate will be responsible for supporting the enrollment of patients into clinical trials through recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol...
-
Clinical Research Manager
3 days ago
Gainesville, Florida, United States InsideHigherEd Full timeClinical Research ManagerThe Department of Medicine, Division of Infectious Diseases and Global Medicine is seeking a full-time Clinical Research Manager. This position is located in the Department of Medicine, Division of Infectious Diseases and Global Medicine. Under the direction of the Division Administrator and Division Chief, this position will be...
-
Biological Researcher II
2 weeks ago
Gainesville, Florida, United States InsideHigherEd Full timeJob Title: Biological Scientist IIThis is an intermediate-level position in a research lab testing viral vector-based gene therapies for the treatment of inherited disease. The successful candidate will be responsible for following Standard Operating Procedures (SOPs) for molecular analysis, including DNA and RNA isolation and real-time PCR. They will also...
-
Clinical Research Coordinator I
3 days ago
Gainesville, Florida, United States University of Florida Full timeJob Summary:The University of Florida College of Nursing is seeking a part-time Clinical Research Coordinator I to support daily operations for a large behavioral clinical trial. The successful candidate will oversee daily operations and workflow, prepare study materials, and ensure proper organization of study files.Key Responsibilities:Oversee daily...
-
Clinical Research APRN
3 weeks ago
Gainesville, Florida, United States University of Florida Full timeJob Title: Clinical Research APRNAt the University of Florida, we are seeking a highly skilled Clinical Research APRN to join our team. As a key member of our neuro-oncology department, you will be responsible for coordinating and overseeing the patient services and administrative activities of our outpatient clinic.Key Responsibilities:Plan, coordinate, and...
-
Research Administrator II
4 weeks ago
Gainesville, Florida, United States InsideHigherEd Full timeJob SummaryWe are seeking a highly skilled Research Administrator II to join our team at the University of Florida. The successful candidate will be responsible for post-award functions, including award set-up and modifications, as well as pre-award functions, such as proposal development and submission. The ideal candidate will have a strong background in...
-
Clinical Investigator Clinician-Researcher
2 weeks ago
Gainesville, Florida, United States University of Florida Full timeJob Title:Clinical Investigator Clinician-ResearcherJob Summary:The University of Florida Department of Medicine is seeking a Clinical Investigator Clinician-Researcher for the Division of Hematology/Oncology at the Assistant/Associate/Full Professor level. The successful candidate will have a primarily clinical assignment, but will also be expected to...
-
Research Nurse Specialist
2 months ago
Gainesville, Florida, United States Northeast Georgia Health System, Inc Full timeJob SummaryWe are seeking a highly skilled and experienced Clinical Research Nurse Coordinator to join our team at Northeast Georgia Health System, Inc. The successful candidate will be responsible for coordinating, implementing, and evaluating clinical research trials, ensuring compliance with regulatory requirements and maintaining accurate documentation...
-
Clinical Research APRN
7 days ago
Gainesville, Florida, United States University of Florida Full timeClinical Research APRN - Neuro-OncologyJoin the University of Florida's esteemed team as a Clinical Research APRN - Neuro-Oncology. This pivotal role demands a skilled professional to oversee the patient services and administrative activities of the neuro-oncology outpatient clinic. As a key member of the team, you will ensure that all programs, activities,...
-
Regulatory Compliance Specialist
1 month ago
Gainesville, Florida, United States Exactech Full timeJob OverviewExactech is seeking a highly skilled Regulatory Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with global regulatory requirements and maintaining our company's reputation for excellence.Key ResponsibilitiesRegulatory Submissions: Prepare and maintain FDA...
-
Regulatory Compliance Specialist
1 week ago
Gainesville, Florida, United States Exactech Full timeJob OverviewExactech is seeking a highly skilled Regulatory Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with global regulatory requirements and maintaining overall regulatory compliance for the company.Key ResponsibilitiesRegulatory Submissions: Prepare and maintain FDA...
-
Neuro-Oncology Clinical Research APRN
3 weeks ago
Gainesville, Florida, United States University of Florida Full timeJob SummaryWe are seeking a highly skilled and experienced Neuro-Oncology APRN to join our team at the University of Florida. The successful candidate will be responsible for providing clinical research and administrative oversight in neuro-oncology, working closely with the Associate Director of Clinical Research and the Chief of Neuro-Oncology.Key...
-
Clinical Research Nurse Coordinator
2 months ago
Gainesville, Florida, United States Northeast Georgia Health System Full timeJob Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryAccountable for the coordination, execution, and assessment of clinical research trials. This encompasses all stages of research: Study Initiation, Execution,...
-
Clinical Research Nurse Manager
2 months ago
Gainesville, Florida, United States Northeast Georgia Health System Full timeJob Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryThe role involves overseeing, executing, and assessing clinical research trials. This encompasses all stages of research: Initiation, Execution, Completion, and...
-
Clinical Informatics Analyst II
4 weeks ago
Gainesville, Florida, United States Open Systems Full timeJob SummaryThe Clinical Informatics Analyst II provides advanced-level support for multi-user clinical operating systems and applications, including MyChart and ambulatory systems. This role involves the installation, configuration, maintenance, and support of clinical systems, translating end-user needs into optimized configurations and workflows.Key...
-
Clinical Research Nurse Coordinator
2 months ago
Gainesville, Florida, United States Northeast Georgia Health System Full timeJob Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryThe Research Nurse Coordinator is accountable for the organization, execution, and assessment of clinical research trials. This encompasses all stages of research:...
-
Clinical Informatics Analyst II
3 days ago
Gainesville, Florida, United States Northeast Georgia Health System Inc Full timeAbout the Role:As a Clinical Informatics Analyst II at Northeast Georgia Health System Inc, you will provide intermediate-level support for multi-user clinical operating systems, hardware, and software tools. This includes installation, configuration, maintenance, training, and support of these systems.Key Responsibilities:Assess current practice and...
-
Clinical Investigator Clinician-Researcher
2 weeks ago
Gainesville, Florida, United States InsideHigherEd Full timeJob DescriptionThe Department of Medicine is seeking a full-time faculty clinical investigator clinician-research track position for the Division of Hematology/Oncology at the Assistant/Associate/Full Professor level.This position seeks an ABIM certified (or eligible) hematologist-oncologist with experience in hematologic malignancies and blood and marrow...
Clinical Research Regulatory Specialist II
2 months ago
The University of Florida is seeking a dedicated and detail-oriented individual for the role of Research Regulatory Analyst II. This full-time position is integral to the management of research compliance and regulatory affairs within the institution.
Key Responsibilities:
- Correspondence Management: Generate precise and professional correspondence related to research protocols, including approval letters and notifications of required changes.
- Liaison Duties: Serve as the primary point of contact between reviewers and principal investigators, ensuring clear communication regarding the status of submissions.
- IRB Submission Evaluation: Assess and review Institutional Review Board (IRB) submissions to ensure compliance with applicable regulations.
Full Board Meeting Contributions:
- Document meeting minutes during Full Board meetings, ensuring adherence to federal regulatory standards.
- Draft and distribute letters to principal investigators based on meeting outcomes and reviewer feedback.
- Collaborate with the IRB Chair to address any issues arising during meetings.
- Prepare finalized minutes for Board approval and coordinate virtual meetings.
Preparation for Board Meetings:
- Develop agendas for IRB Full Board meetings and ensure research proposals meet the necessary guidelines.
- Review and process submissions through the electronic system, ensuring accuracy and completeness.
- Analyze proposals to confirm alignment with federal, state, and institutional regulations.
Qualifications:
A Bachelor's degree in a relevant field and a minimum of two years of experience in research compliance or regulatory affairs is required. A strong understanding of federal, state, and local regulations is preferred, along with excellent communication skills and the ability to work collaboratively with diverse teams.
Skills:
Proficiency in Microsoft Office, Zoom, and myIRB is essential. The ideal candidate will possess strong organizational skills, attention to detail, and the ability to work independently.
Application Process:
Interested candidates should prepare a cover letter, resume, and a list of professional references. A background check will be conducted as part of the hiring process. This position is committed to fostering an inclusive environment and does not discriminate based on race, gender, or other protected characteristics.
