Clinical Research Regulatory Coordinator, School of Medicine, Clinical Research Office

2 days ago

Richmond, Virginia, United States Commonwealth of Virginia Full time
Job Summary

The School of Medicine at Virginia Commonwealth University is seeking a highly skilled Clinical Research Regulatory Coordinator to join our team. This role will be responsible for providing regulatory management and support for clinical trials, ensuring compliance with federal and state regulations, and collaborating with study teams to facilitate the activation and management of clinical research studies.

Key Responsibilities
  • Provide regulatory management and support for clinical trials, including preparation and submission of IRB documents and protocols.
  • Ensure compliance with federal and state regulations, including GCP/ICH guidelines and human subject protection regulations.
  • Collaborate with study teams to facilitate the activation and management of clinical research studies, including site selection visits and study selection activities.
  • Develop and maintain Standard Operating Procedures (SOPs) to support regulatory compliance and best practices in clinical research.
  • Provide education and guidance to investigators and study teams on regulatory compliance and best practices in clinical research.
Requirements
  • Bachelor's degree or equivalent experience.
  • At least 2 years of direct Clinical Research Coordinator experience.
  • 1 or more years' experience in Clinical Research Regulatory affairs.
  • Demonstrated understanding of clinical research, including all types and funding sources.
  • Maintain CITI credentials for Human Subjects Protection and Good Clinical Practice (GCP).
  • Excellent oral and written communication skills.
  • Ability to set priorities, make timely decisions, and meet deadlines.
  • Ability to work collaboratively in a large and complex organization.
Preferred Qualifications
  • Regulatory management of multi-site studies.
  • Clinical research certification or ability to obtain.
  • Experience in an academic medical center environment.
  • Prior experience using OnCore or other clinical trial management systems.

This is a remote-hybrid eligible position, with the selected candidate required to come into the office on VCU's MCV-Health Campus when needed. The School of Medicine is committed to fostering a diverse and inclusive environment, and we encourage all qualified applicants to apply.

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