Clinical Research Regulatory Specialist

2 weeks ago

Charlottesville, Virginia, United States Commonwealth of Virginia Full time
Join the Commonwealth of Virginia as a Clinical Research Regulatory Specialist

The Clinical Research Regulatory Specialist is responsible for autonomously preparing, processing, submitting, and maintaining critical regulatory documentation for clinical research protocols within the Commonwealth of Virginia. This essential position ensures the prompt submission of documents for evaluation by pertinent internal committees and sponsors. Collaborating effectively with a dedicated team, the specialist plays a vital role in upholding efficient and compliant regulatory procedures for assigned clinical research projects.

KEY RESPONSIBILITIES
  • Prepare and submit study protocols, informed consent documents (ICD), and all necessary paperwork to the Institutional Review Board (IRB) for each clinical trial.
  • Submit required documentation to internal review committees.
  • Adhere to committee and sponsor timelines, revise documents as needed, and track the review and approval status.
  • Keep the Principal Investigator (PI) and Clinical Research Coordinator (CRC) informed of progress.
  • Draft, process, collect, and maintain essential regulatory documentation.
  • Submit reports on adverse events, protocol modifications, personnel changes, and other required submissions.
  • Ensure adherence to regulatory standards using management systems.
  • Collaborate with sponsors to ensure compliance with regulatory documentation.
  • Prepare responses to quality assurance evaluations and other findings.
  • Notify relevant parties of changes in study regulatory status.
  • Provide accurate information regarding the study to stakeholders.
  • Act as the primary liaison with sponsors.
  • Compile study status reports.
  • Stay informed about regulations governing clinical trials.
  • Participate in team meetings.
MINIMUM QUALIFICATIONS

Education: High school diploma
Experience: A minimum of two years of relevant experience or equivalent educational background.

PHYSICAL REQUIREMENTS

This position primarily involves sedentary work with significant computer usage and occasional travel for meetings.

*This role supports a hybrid work model, blending in-person and remote work.*

APPLICATION PROCESS

To apply for this position, please visit the appropriate careers website and search for the job listing. Ensure your application includes a CV or Resume and a Cover Letter to be considered for the role.

References will be obtained through a standardized process during the final interview stage. For inquiries about the application process, please reach out to the designated recruiting specialist.

The Commonwealth of Virginia is deeply committed to diversity and equal opportunity employment. Qualified applicants will be evaluated without regard to various factors including age, disability, gender identity, national origin, race, religion, and more.

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