Senior Clinical Research Associate

February 8

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Iovance Biotherapeutics, Inc.

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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.

Immuno Oncology • Autologous Cell Therapy • Tumor Infiltrating Lymphocytes (TIL) • Novel Cancer Immunotherapies • cell therapy

501 - 1000 employees

Founded 2014

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Independently manages the study start up activities for multi-center, US and/or global based studies. • Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance • Provides monitoring oversight by reviewing monitoring schedules, metrics and reports. • Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs. • Leads or participates in vendor management activities (e.g., Central Laboratory, Central Imaging, CRO) • Performs in-house routine data listings review • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out. • Supports CTM and cross-functional representatives as required in relationship management tasks (e.g., contracts, study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities. • Mentors and coaches’ junior staff new to Clinical Research (e.g. Clinical Trial Assistants) • Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Performs other duties and assignments as required for the overall success of the projects. • Duties may change based on the status of clinical programs and the ongoing needs of the organization. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Requirements

• BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring / clinical trial management and vendor experience in accordance with CFR, GCP and ICH Guidelines • Clinical Operations 4 to 8 years experience • Most have experience in Solid Tumor or Cell Therapy • Must have strong knowledge of ICH/GCP guidelines • Must have strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring • Strong experience managing early to late phases clinical studies and working with CROs and other study vendors • Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability • Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language • Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project • Ability to “roll up your sleeves” and individually contribute results to a research and development effort