Note: The job is a remote job and is open to candidates in USA. Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. The Clinical Trial Assistant provides administrative and project-specific support to the Clinical Operations Team related to clinical trials, including coordinating study materials and maintaining communication with investigator sites.
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 files
- Perform administrative and clerical duties
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
- Perform miscellaneous duties as assigned
Skills
- 2 + years of pharmaceutical or biotech-related/clinical research, oncology or research experience
- Excellent verbal and written communication skills
- Attention to detail
- Demonstrated ability to work independently and exhibit initiative
- Computer literacy required (MS word, MS Excel, MS PowerPoint and MS Project)
- Bachelor's Degree or Equivalent in a scientific or health care discipline preferred
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