Senior Clinical Research Associate

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🇺🇸 United States – Remote

💵 $130k - $150k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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

• Independently manage study start-up activities for multi-center US and/or global studies • Perform on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess site and CRA performance • Provide monitoring oversight by reviewing monitoring schedules, metrics, and reports • Conduct clinical site training and monitor adherence to protocol, applicable GCP/ICH guidelines, regulations, statutes, and SOPs • Lead or participate in vendor management activities, including Central Laboratory, Central Imaging, and CRO vendors • Perform in-house routine data listings review • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Support CTM and cross-functional representatives with contracts, study logistics, patient enrollment, safety, and data management • Mentor and coach junior Clinical Research staff, such as Clinical Trial Assistants • Assist with protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study documents • Assist in managing and/or leading day-to-day operations of assigned studies in compliance with GCP/ICH and regulatory requirements • Perform other duties and assignments required for project success • 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 • 8+ years of clinical operations experience • Experience in Solid Tumor or Cell Therapy • Strong knowledge of ICH/GCP guidelines • 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 • 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 MS Word, PowerPoint, Excel and Project • Ability to remain in a stationary position standing or sitting for prolonged periods • Ability to move about inside an office and exert up to 10 pounds of force occasionally or negligible force frequently or constantly • Visual acuity for preparing and analyzing data and figures, viewing a computer screen, and extensive reading • Ability to perform repetitive motion involving the wrist, hands, and/or fingers • Ability to communicate with others to exchange information • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion • Ability to handle work-related stress, multiple priorities, and deadlines • Ability to travel up to 25%

🏖️ Benefits

• Reasonable accommodations may be made upon request • Diverse and inclusive work environment • Equal-opportunity employment