- Prepare and submit protocol, informed consent form (ICF), and all required documents to Institutional Review Board (IRB) of record for each study assigned.
- Submit required documents to internal review committees as applicable (e.g. HIRE).
- Adhere to committee and sponsor deadlines, edit documents as requested by review committees, and follow progress of the review and approval process of each committee.
- Communicate progress with Principal Investigator (PI) and Clinical Research Coordinator (CRC).
- Draft, process, collect and maintain essential regulatory documents.
- Process and submit adverse events reports, protocol and informed consent amendments/revisions, personnel changes, study continuations, Investigational New Drug (IND) safety reports, protocol deviations, and investigator brochures.
- Maintain regulatory compliance utilizing the clinical trial management system and the e-regulatory system. Administer and maintain physical and electronic trial files, as applicable.
- Collaborate with clinical trial sponsors to maintain regulatory document compliance.
- Prepare and transmit responses to findings generated from internal and external quality assurance reviews, monitoring visits, and/or audits.
- Notify PI and/or supervisor of study regulatory status changes.
- Convey accurate and comprehensive study information to PI, CRCs, 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 performs all activities in compliance with these regulations.
- Attend team meetings.
- This position is open to a hybrid work schedule (expected to work both in-person and remote).
- CV or Resume
- Cover letter
-
Compliance Coordinator
6 days ago
Allen Spolden Charlottesville, United StatesJob Description · Responsibilities: Implement strategies to ensure a level of excellence at all sites by facilitating Ongoing Monitoring and Continuous Quality Improvement activities · Implement a qualitative/quantitative system of monitoring program content areas including fac ...
-
Regulatory Compliance Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe School of Medicine Clinical Trials Office is searching for a Regulatory Compliance Coordinator. The coordinator is responsible for independently preparing, processing, submitting and maintaining regulatory documents required for clinical protocols. This includes preparing and ...
-
Regulatory Compliance Coordinator
4 days ago
University of Virginia Charlottesville, United StatesThe School of Medicine Clinical Trials Office is searching for a Regulatory Compliance Coordinator. The coordinator is responsible for independently preparing, processing, submitting and maintaining regulatory documents required for clinical protocols. This includes preparing and ...
-
Regulatory Compliance Coordinator
1 week ago
University of Virginia Charlottesville, United StatesThe School of Medicine Clinical Trials Office is searching for a Regulatory Compliance Coordinator. The coordinator is responsible for independently preparing, processing, submitting and maintaining regulatory documents required for clinical protocols. This includes preparing and ...
-
Environmental Compliance Coordinator
3 weeks ago
Dominion Energy Fishersville, United StatesEnvironmental Compliance Coordinator (Intermediate or Senior) (Innsbrook or Fishersville, VA) · **Date:** May 16, 2024 · **Location:** GLEN ALLEN, VA, US, 23060FISHERSVILLE, VA, US, 22939 · **Company:** Dominion Energy · At Dominion Energy we love our jobs. Thats right. Love. ...
-
Regulatory Clinical Research Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe Cancer Center's Office of Clinical Research (CC OCR) is looking for individuals to join their team as a Regulatory Coordinator. The Regulatory Coordinator will be responsible for independently submitting and processing UVA Cancer Center protocols for regulatory review by Prot ...
-
Referral/Billing/Reimbursement Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesProvide billing and compliance support within the Division of Radiation Oncology to include; compliance and charge capture, referral/medical necessity, denial management/data collection and follow up, and project management. This position provides business support to clinic and a ...
-
Regional Director, Home Care
1 week ago
InnovAge Charlottesville, United States Full timeThe Regional Director of In-Home Services oversees the administration of the home care agency for a designated geographic region. Key responsibilities include insuring compliance with regulatory (federal, state and local) requirements, management of staff and contracted services, ...
-
Transplant Quality Coordinator
4 weeks ago
Virginia Jobs Charlottesville, United StatesAssists in implementation of quality improvement and patient safety initiatives for transplant services. Responsible for policy implementation and compliance of all donation and transplant related regulatory agencies including CMS UNOS and The Joint Commission. · Develops and mai ...
-
Human Resources Generalist
1 week ago
Hospice of the Piedmont Charlottesville, United StatesJob Type Full-time Description Hospice of the Piedmont is dedicated to providing compassionate end-of-life care and support to patients and their families. We are looking for a motivated and detail-oriented full-time Human Resources Generalist to join our team. The Human Resour ...
-
Residency Program Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe UVA Department of Anesthesiology is seeking a full-time Residency Program Coordinator (RPC) to join the Department's Medical Education Team. The successful applicant will coordinate day-to-day operations of the program and serve as an important liaison with Program Directors, ...
-
Clinical Research Coordinator 4
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe Department of Pediatrics in the University of Virginia's (UVA) School of Medicine is seeking candidates for a Clinical Research Coordinator (CRC) Team Lead, licensed or non-licensed, at the experience level of a CRC 4. The Department's research mission is comprehensive and in ...
-
Director, Accreditation
1 week ago
Commonwealth of Virginia Charlottesville, United StatesJob Profile Summary · Plans, implements, and directs activities that supports the Medical Center's compliance with state and federal regulatory requirements and associated accreditation requirements. This includes, but is not limited to, acting as the on-site survey coordinator, ...
-
Commonwealth of Virginia Charlottesville, United StatesThe Division of Infectious Diseases and International Health at the University of Virginia (UVA) School of Medicine is currently seeking applicants for Clinical Research Coordinators (CRC), non-licensed or licensed, at various skill and experience levels (CRC 2 or 3) to join the ...
-
Ambulatory Clinical Program Coordinator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe Clinical Program Coordinator is responsible for oversight of clinical program performance, compliance and reporting. The Clinical Program Coordinator serves as a clinical resource within the organization to facilitate interprofessional collaboration and promote program object ...
-
Early Employment Coordinator
3 weeks ago
International Rescue Committee Charlottesville, United StatesRequisition ID: req51974 · Job Title: Early Employment Coordinator · Sector: Employment · Employment Category: Regular · Employment Type: Full-Time · Compensation: USD - Hourly · Location: Charlottesville, VA USA · Work Arrangement: Hybrid · Job Description · Job Overview: The E ...
-
IR Education Program Coord
1 week ago
Commonwealth of Virginia Charlottesville, United StatesCoordinator of the student program for Interventional Radiology (IR). Orchestrate daily student clinical rotations. Coordinates and collates the evaluation of students clinical and didactic performance. Schedule student on-call, student classes, and clinical rotations. Work with ...
-
Commonwealth of Virginia Charlottesville, United StatesThe Department of Pediatrics at the University of Virginia (UVA) School of Medicine seeks two candidates to fill our Medical Education Coordinator and/or Assistant positions. The ideal candidate(s) should possess excellent communication and presentation skills, attention to detai ...
-
Radiology Fellowship Administrator
1 week ago
Commonwealth of Virginia Charlottesville, United StatesThe UVA Department of Radiology and Medical Imaging is seeking a full-time Radiology Fellowship Administrator to join the Department's Medical Education Team. The incumbent will coordinate day-to-day operations of the programs and serve as an important liaison with Program Direct ...
-
Case Manager, Registered Nurse
2 days ago
Interim HealthCare - Richmond, VA Charlottesville, United StatesJob Summary: · Interim HealthCare, an industry-leading home healthcare and medical staffing agency, is seeking a skilled and compassionate Registered Nurse (RN) to join our team as Case Manager in Charlottesville, VA. · This is a contracted position with a pay rate of $52 per hou ...
Regulatory Compliance Coordinator - Charlottesville, United States - State of Virginia
Description
The School of Medicine Clinical Trials Office is searching for a Regulatory Compliance Coordinator. The coordinator is responsible for independently preparing, processing, submitting and maintaining regulatory documents required for clinical protocols.This includes preparing and submitting the documents required for review by the IRB of record for each study and other internal review committees, as applicable.
This position works with a team to ensure the efficient and compliant regulatory management of clinical research protocols to which they are assigned.
The incumbent serves as the contact with the relevant internal regulatory committees and sponsor representatives.JOB RESPONSIBILITIES
MINIMUM REQUIREMENTS
Education:
High school diploma
Experience:
At least two years of relevant experience. Any combination of equivalent education and experience may be considered.
PHYSICAL DEMANDS
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.
This position will remain open until filled. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen is required for this position prior to employment.
TO APPLY
Please apply through Careers at UVA , and search for R Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'.
Complete an application online with the following documents:
References will be completed via UVA's standardized process Skill Survey during the final phase of the interview process. For questions about the application process, please contact Jeremy Brofft, Senior Recruiting Specialist at .
For more information about UVA and the Charlottesville community please see and .
The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician's Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff.
All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.
