Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.
Overview
The Clinical Trial Assistant provides the Clinical Operations Team members with administrative and project-specific support related to the conduct of clinical trials. This includes assisting with study team activities and performing administrative clerical duties. The Clinical Trial Assistant is also responsible for obtaining study materials and tracking of invoices and clinical study trackers.
Essential Functions and Responsibilities
- Adhere to Clinical Standard Operating Procedures and Good Clinical Practice ICH Guidelines.
- Assist in contacting investigator sites to provide study specific information.
- Ensure receipt, completeness and accuracy of clinical and administrative documents.
- Coordinate distribution and shipment of study-related materials.
- Coordinate investigator site/payment as needed.
- Maintain telephone contact with sites, contract research organization personnel, vendors and CRAs as needed.
- Facilitate flow and maintenance of correspondence with sites.
- Attend clinical project team meetings and takes minutes.
- Contract, invoice and budget management and tracking.
- Assist in coordination of study initiation documentation materials.
- Responsible for compiling/QC checking/generating copies of clinical documents that are intended for submissions including 1572s (original and updated), Informed Consent Form, Protocol and Investigator’s Brochure.
- Coordinate distribution of study team materials and meeting minutes.
- Draft and prepare documents for mass mailings (e.g., protocol amendments).
- Assist with preparation of presentation materials.
- Maintain central registry of contact information for clinical sites, contract research organizations, vendors and CRAs.
- Set up teleconference calls with sites and team and record minutes.
- Maintain central monitoring calendar for all site visits.
- Create and maintain Central Clinical f