Regulatory Clinical Research Coordinator
1 week ago
The Commonwealth of Virginia's Office of Clinical Research is seeking a highly skilled Regulatory Clinical Research Coordinator to join their team. As a key member of the team, you will be responsible for ensuring the efficient and compliant regulatory management of clinical research protocols throughout the Cancer Center.
Key Responsibilities:- Draft and submit Protocol Review Committee (PRC) submissions.
- Write abbreviated protocols and consents for Institutional Review Board (IRB) submission.
- Prepare Central Institutional Review Board (CIRB) expedited submissions to the IRB.
- Process adverse events, amendments/revisions, personnel changes, study continuations, Investigational New Drug (IND) safety reports, and investigator brochures.
- Maintain regulatory compliance using informatics platform OnCore.
- Administer physical and electronic trial files.
- Draft, collect, and maintain essential regulatory documents.
- Work with clinical trial sponsors to maintain protocol compliance.
- Submit Informed Consent Form (ICF) language to appropriate committees.
- Respond to Data and Safety Monitoring Committee (DSMC) reports.
- Prepare and transmit responses generated from internal Post Approval Monitoring (PAM) audits.
- Adhere to deadlines, edit material as requested by governing boards, and follow progress of approval steps for trial protocols.
- Work on the preparation, completion, and organization of regulatory documentation for each clinical trial as needed and primary assignment allows.
- Notify Principal Investigator and/or supervisor of study regulatory status changes.
- Convey accurate and comprehensive study information to Principal Investigator, supervisory personnel, study sponsor, members of the interdisciplinary team involved in the studies, and peers.
- Serve as the liaison with the sponsor for all assigned studies.
- Prepare study status reports as required.
- Keep current in federal, state, and local regulations governing clinical trial activities and perform all activities in compliance with these regulations.
- Attend team meetings.
- Compliance Coordinator Trainee: High School Diploma, no experience required.
- Compliance Coordinator: High School Diploma, at least 2 years of relevant experience.
This is primarily a sedentary job involving extensive use of desktop computers.
Hiring Ranges:- Compliance Coordinator Trainee: $45,000-$50,000.
- Compliance Coordinator: $51,000-$56,000.
Please note that this is a restricted position and continuation is dependent upon the availability of the position, funding, and satisfactory performance. This position cannot offer sponsorship.
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Regulatory Clinical Research Coordinator
3 weeks ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeRegulatory Clinical Research CoordinatorThe Commonwealth of Virginia's Office of Clinical Research is seeking a highly skilled Regulatory Clinical Research Coordinator to join their team. As a key member of the team, you will be responsible for ensuring the efficient and compliant regulatory management of clinical research protocols throughout the Cancer...
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Regulatory Affairs Clinical Research Coordinator
1 month ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timePosition OverviewThe Commonwealth of Virginia is seeking qualified candidates for the role of Regulatory Clinical Research Coordinator within the Cancer Center's Office of Clinical Research (CC OCR). This pivotal role involves the independent submission and management of clinical research protocols for regulatory assessment by various committees and...
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Clinical Research Coordinator
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Clinical Research Coordinator
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1 day ago
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Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryWe are seeking a highly skilled Clinical Research Coordinator to join our team at the University of Virginia's Division of Cardiovascular Medicine. The successful candidate will be responsible for coordinating all aspects of clinical research, from study start-up to archiving of study records. This is a full-time, benefited position that requires...
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3 weeks ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryThe Department of Pediatrics at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator to support clinical research efforts in various divisions. The successful candidate will assist Principal Investigators and faculty in conducting clinical trials, including NIH-sponsored and investigator-initiated studies....
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4 weeks ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryThe Department of Pediatrics at the University of Virginia's School of Medicine is seeking a Clinical Research Coordinator to support clinical research efforts in various divisions. The successful candidate will work closely with Principal Investigators and experienced CRCs to learn the full scope of clinical research duties, including...
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Clinical Research Coordinator
4 weeks ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryWe are seeking a highly skilled Clinical Research Coordinator to join our team at the University of Virginia's Division of Cardiovascular Medicine. As a Clinical Research Coordinator, you will play a critical role in the success of our research studies, working closely with physicians, research staff, and study subjects to coordinate all aspects...
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Clinical Research Coordinator
4 weeks ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryWe are seeking a highly motivated Clinical Research Coordinator to join our team at the Beirne B. Carter Center for Immunology Research and the Precision ImmunoMedicine (iPRIME) Initiative at the University of Virginia. As a key member of the Prominence-to-Preeminence (P2PE) STEM initiative, you will play a crucial role in implementing precision...
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2 days ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob Title: Clinical Research CoordinatorThe Beirne B. Carter Center for Immunology Research and the Precision ImmunoMedicine (iPRIME) Initiative at the University of Virginia is seeking a highly motivated Clinical Research Coordinator to become a key member of the Prominence-to-Preeminence (P2PE) STEM initiative titled "iPRIME: Immunology and Informatics for...
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Regulatory Affairs Research Associate
1 month ago
Charlottesville, Virginia, United States Commonwealth of Virginia Full timePosition Overview The Commonwealth of Virginia is seeking dedicated individuals to join our team as Regulatory Coordinators within the Office of Clinical Research. The Regulatory Coordinator will play a crucial role in the submission and management of clinical research protocols for regulatory evaluation by various committees and authorities, including the...
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Clinical Research Coordinator
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Charlottesville, Virginia, United States Commonwealth of Virginia Full timeJob SummaryThe Commonwealth of Virginia is seeking a highly skilled Clinical Research Coordinator to join our Nephrology Division. As a key member of our team, you will be responsible for coordinating all aspects of clinical research from study start-up through archiving of study records.Key ResponsibilitiesPrepare regulatory submissions and review protocols...
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Charlottesville, Virginia, United States Commonwealth of Virginia Full timeClinical Research Coordinator Job DescriptionThe University of Virginia's Cancer Center Office of Clinical Research is seeking a highly skilled Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will play a critical role in conducting clinical trials, working with research participants, and ensuring the smooth operation...
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Clinical Research Coordinator 1 Non-Licensed
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