Clinical Trial Assistant

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• 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.

🎯 Requirements

• 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)

🏖️ Benefits

• N/A