Study Coordinator

UNC-Chapel HillChapel Hill, NC
1d

About The Position

The UNC LCCC Cellular Therapy Program (https://unclineberger.org/cellular-immunotherapy/) is seeking a study coordinator to facilitate complex investigational and FDA -approved cellular and gene therapies within according to federal regulations, Good Clinical Practice, and local and institutional policies. This position will ensure that patients who are being evaluated for and undergoing cell therapy receive comprehensive, coordinated care in an organized and high quality manner. The study coordinator will work with a multi-disciplinary team of pre-clinical faculty, clinical faculty, and UNC Medical Center staff to design, develop and deliver investigational and/or FDA -approved cellular and gene therapies to adult and pediatric populations. This position will also provide strategic planning and execution of commercial and research Tumor Infiltrating Lymphocyte ( TIL ) cell therapies and serve as a liaison with oncology, surgical and pathology teams during tumor tissue procurement and shipment. This position will further coordinate the conduct of early phase cellular and gene therapy clinical trials, including patient and data management. The coordinator will maintain the quality of research by addressing patient safety and regulatory compliance.

Responsibilities

  • Facilitate complex investigational and FDA -approved cellular and gene therapies within according to federal regulations, Good Clinical Practice, and local and institutional policies.
  • Ensure that patients who are being evaluated for and undergoing cell therapy receive comprehensive, coordinated care in an organized and high quality manner.
  • Work with a multi-disciplinary team of pre-clinical faculty, clinical faculty, and UNC Medical Center staff to design, develop and deliver investigational and/or FDA -approved cellular and gene therapies to adult and pediatric populations.
  • Provide strategic planning and execution of commercial and research Tumor Infiltrating Lymphocyte ( TIL ) cell therapies and serve as a liaison with oncology, surgical and pathology teams during tumor tissue procurement and shipment.
  • Coordinate the conduct of early phase cellular and gene therapy clinical trials, including patient and data management.
  • Maintain the quality of research by addressing patient safety and regulatory compliance.
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