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Regulatory Coordinator, Compliance Analyst

University of Virginia
$0 - 0
Posted Nov 09
Full Time
Charlottesville, Virginia
This job is expired. See open roles here.

The Division of Gastroenterology and Hepatology at the University of Virginia, Department of Medicine is seeking a Regulatory Coordinator, Compliance Analyst to join the team.

Compliance Analysts execute the operational activities of a compliance program such as Immigration, Risk Management, Office of Equal Opportunity, Institutional Review Board, Athletics, and Office of Sponsored Programs. They are knowledgeable about the complex legal and regulatory issues potentially impacting University operations, and follow established protocol when dealing with compliance procedures, such as compliance reporting and document review. Analysts exercise some degree of independence and autonomy, but will seek help before handling more complex functions.

**Overarching Job Duties

**

  • Aid in executing compliance program components, including protocol and consent form review, record keeping, reporting, and evaluation.
  • Perform preliminary review of protocols and identify potential concerns, reporting any to supervisor.
  • Update database, maintain files, and handle database issues as needed.
  • Aid in preparing reports, presentations, and strategic materials for key review committees.
  • May perform all duties of a Compliance Coordinator, as needed.
  • In addition to the above job responsibilities, other duties may be assigned.

**Regulatory Documentation Preparation

**

  • Prepare clinical research regulatory documents for studies as assigned including informed consent forms, protocols, manuals and training logs etc. in compliance with federal regulations, ICH and GCP guidelines
  • Prepare and manage IRB documents and protocols for submission using both Central and local IRBs
  • Work with network coordinators and investigators on ensuring regulatory compliance on all active and future studies

**Regulatory Oversight

**

  • Coordinate program staff and study staff training as it relates to regulatory compliance
  • Stay up to date on internal trial development and submission policies

**Regulatory Activation

**

  • Create and maintain electronic and/or paper study binders for all industry and investigator initiated clinical trials including trial master file, investigator site files and program training files
  • Coordinate with investigators, pharmacy, clinics to ensure smooth patient progression through study
  • Will complete all required training sessions, internally and externally

**Systems Utilized In This Position Include

**

  • Oncore
  • Florence e-regulatory
  • UVA’s proprietary systems for Study Set up and local IRB

**Minimum 1 Year Of Regulatory Experience

** Hybrid or Fully Remote eligible

Part time hours may be considered

Perform other duties as needed

**Minimum Requirements

** Education: Bachelor's degree. 4 years of relevant experience may be considered in lieu of a degree.

Experience: At least two years of relevant experience.

Licensure: None

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.

**To Apply

** Please apply through Workday, and search for **R0053645

** Internal applicants must apply through their UVA Workday profile by searching 'Find Jobs'

**Complete An Application Online With The Following Documents

**

  • CV
  • Cover letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. _Applications that do not contain all required documents will not receive full consideration.

_ For questions about the application process, please contact Michelle Johnson, Recruiter, at mdj9w@virginia.edu.

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. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. 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.