Clinical Research Professional, Regulatory Affairs Specialist
4 weeks ago
The University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our Cancer Programs, you will play a critical role in supporting the University's mission and commitment to excellence in research and education.
Key Responsibilities- Oversee the start-up process for clinical studies, ensuring timely and efficient execution.
- Support feasibility and scientific review processes, working closely with sponsors, CROs, and internal stakeholders.
- Prepare and submit initial IRB applications, ensuring compliance with regulatory requirements.
- Assist in the preparation of site-adapted informed consent documents and other regulatory materials.
- Collect and complete essential regulatory documentation for study start-up.
- Coordinate contract and budget submissions, ensuring accurate and timely execution.
- Provide ongoing status reports to stakeholders, ensuring transparency and accountability.
- Interact daily with sponsors, CROs, and internal staff, fostering strong relationships and effective communication.
- Bachelor's degree in a related field or equivalent experience.
- 1-3 years of relevant experience in an academic, clinical, or laboratory setting.
- Knowledge of medical and pharmaceutical terminology, as well as regulatory requirements and guidelines.
- Experience working in an academic or clinical setting, with a focus on clinical research and regulatory affairs.
- Excellent communication and interpersonal skills, with the ability to work effectively with diverse stakeholders.
- Experience with FDA regulations, NCI policies, and Good Clinical Practice guidelines.
- Ability to prioritize tasks, manage multiple projects, and meet deadlines in a fast-paced environment.
The University of Cincinnati offers a comprehensive benefits package, including competitive salary, comprehensive insurance plans, flexible spending accounts, and a retirement savings plan. Additionally, UC employees enjoy discounts for on and off-campus activities and services.
As a UC employee, you will be part of a dynamic and inclusive community that values diversity, equity, and inclusion. We offer a range of professional development opportunities, including training, mentorship, and career advancement programs.
Join our team and contribute to the University's mission to advance knowledge, promote innovation, and improve the human condition.
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Cincinnati, Ohio, United States University of Cincinnati Full timeJob OverviewThe University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the integrity and compliance of our clinical research programs.Key ResponsibilitiesOversee the initiation and management of clinical trials, ensuring...
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Cincinnati, Ohio, United States University of Cincinnati Full timeJob OverviewThe University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our regulatory affairs department, you will play a critical role in supporting the University's mission to advance medical research and improve patient outcomes.Essential FunctionsOversee the start-up process for clinical...
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Regulatory Affairs Specialist
6 days ago
Cincinnati, Ohio, United States University of Cincinnati Full timeJob OverviewThe University of Cincinnati is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our research team, you will be responsible for overseeing the start-up process for clinical trials, ensuring compliance with regulatory requirements, and providing exceptional support to our researchers and sponsors.Key...
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Cincinnati, Ohio, United States Thermo Fisher Scientific Full timeJob SummaryWe are seeking a highly skilled Clinical Affairs Manager to join our Regulatory and Clinical Affairs organization. This role will be responsible for ensuring compliance with Good Clinical Practice, regulatory requirements, and FDA submissions for our in vitro diagnostics products.Key ResponsibilitiesParticipate in clinical study planning, core...
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Regulatory Affairs Director
2 weeks ago
Cincinnati, Ohio, United States Smithfield Packaged Meats Corp Full timeJob Title: Director Regulatory AffairsSmithfield Packaged Meats Corp is seeking a highly skilled Director Regulatory Affairs to lead all RA operations and ensure regulatory submissions maintain strict adherence to global requirements. This role will monitor adherence to current Good Manufacturing Practices (cGMP) and ensure the quality and integrity of the...
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Regulatory Affairs Director
2 weeks ago
Cincinnati, Ohio, United States Smithfield Foods Full timeJob Title: Director, Regulatory AffairsSmithfield Foods is seeking a highly skilled and experienced Director, Regulatory Affairs to lead our regulatory affairs team. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory requirements and maintaining the quality and integrity of our products.Key...
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Cincinnati, Ohio, United States University of Cincinnati Full timeJob Title: Director, Quality Assurance and Regulatory AffairsJoin the University of Cincinnati's Hoxworth Blood Center as we seek a highly skilled Director, Quality Assurance and Regulatory Affairs to oversee and direct the coordination of quality assurance and regulatory compliance for our Cellular Therapy, Therapeutic Apheresis, and Transplantation...
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Clinical Research Professional
2 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our Clinical Trials Office, you will play a critical role in supporting the development and implementation of clinical trials, ensuring compliance with regulatory requirements, and providing exceptional...
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Clinical Research Professional
19 hours ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join our team. As a key member of our Clinical Trials Office, you will play a critical role in supporting the development and implementation of clinical trials, ensuring compliance with regulatory requirements, and providing exceptional...
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Clinical Research Professional
2 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob Title: Clinical Research ProfessionalWe are seeking a highly skilled Clinical Research Professional to join our team at the University of Cincinnati. As a key member of our research team, you will be responsible for planning and coordinating clinical research projects, facilitating communication with participants, nurses, physicians, sponsors, and...
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Clinical Research Professional
1 week ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly motivated and detail-oriented Clinical Research Professional to join our team. As a key member of our Clinical Trials Office, you will play a critical role in supporting the development and implementation of clinical trials, ensuring compliance with regulatory requirements, and...
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Clinical Research Professional
3 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join their team. As a key member of the Department of Neurology & Rehabilitation Medicine, this individual will play a crucial role in supporting the development and implementation of clinical research projects.Key ResponsibilitiesPlan...
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Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join our team in the Department of Radiology. As a key member of our research team, you will play a critical role in supporting the development and implementation of clinical research projects, ensuring compliance with regulatory...
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Senior Clinical Research Professional, Radiology
4 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking highly skilled professionals to join its Department of Radiology as Senior Clinical Research Professionals. As a top-tier department with world-renowned faculty and staff, we are committed to transforming the world of medicine through cutting-edge research and innovative clinical...
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Senior Clinical Research Professional, Radiology
3 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking two full-time Senior Clinical Research Professionals to join the Department of Radiology. As a top-tier department with world-renowned faculty and staff, we are committed to transforming the world of medicine through cutting-edge research and clinical care.Key ResponsibilitiesPlan and...
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Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly motivated and detail-oriented Clinical Research Professional to join the Department of Radiology. As a key member of the Radiology Imaging Services Core Lab team, you will play a critical role in supporting the development and implementation of clinical research...
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Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join our team in the Department of Neurology and Rehabilitation Medicine. As a key member of our research team, you will play a critical role in supporting the design, implementation, and evaluation of clinical research studies.Key...
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Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join our team in the Department of Neurology and Rehabilitation Medicine. As a key member of our research team, you will play a critical role in supporting the planning, coordination, and execution of clinical research projects.Key...
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Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking a highly skilled Clinical Research Professional to join their team in the Department of Neurology and Rehabilitation Medicine. As a key member of the research team, you will play a critical role in supporting the development and implementation of clinical research projects.Key...
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Senior Clinical Research Professional, Radiology
4 weeks ago
Cincinnati, Ohio, United States InsideHigherEd Full timeJob OverviewThe University of Cincinnati College of Medicine is seeking highly skilled and motivated individuals to fill two full-time Senior Clinical Research Professional positions in the Department of Radiology. As a top-tier department with world-renowned faculty and staff, we are committed to transforming the world of medicine through cutting-edge...
