Senior Clinical Research Associate

🕒 September 1

🇺🇸 United States – Remote

💵 $130k - $150k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 14%

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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

• Manage study start-up activities for multi-center US and/or global studies • Review and track CRO monitoring visit reports, follow-up letters, action items, performance trends, and escalations • Provide monitoring oversight through schedules, metrics, KPI/KRI review, enrollment and site activation tracking, and protocol deviation follow-up • Support clinical site and CRO training and oversee adherence to protocol, GCP/ICH guidelines, regulations, statutes, and SOPs • Lead or participate in vendor management, including deliverable and timeline tracking, change orders, invoice and budget reconciliation support • Perform routine in-house data listings review • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Serve as CTM delegate and coordinate clinical study activities with cross-functional representatives • Contribute to study timelines, risk logs, meeting agendas, and minutes • Mentor and coach junior clinical research staff • Assist with protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study documents • Support day-to-day study operations and compliance with GCP/ICH and regulatory requirements • Maintain and quality-review the Trial Master File and support inspection readiness • Contribute to study-level plans and clinical operations process and SOP improvement • Prepare study status updates and presentations for clinical leadership and cross-functional meetings • Perform other duties as required and adhere to company values, policies, procedures, and business ethics

🎯 Requirements

• BS/BA, RN, or equivalent with at least 4 years of clinical trial management, clinical operations, and vendor oversight experience in a sponsor or CRO setting 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 • Experience with eTMF and CTMS systems and tracking CRO/vendor budgets and invoices preferred • Excellent interpersonal, written and verbal communication, administrative, and computer skills • Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills • Good command of written and spoken English • Excellent skills in MS Word, PowerPoint, Excel, and Project • Ability to contribute individually to research and development efforts • Ability to remain stationary 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 computer screens, and extensive reading • Ability to perform repetitive wrist, hand, and finger movements • Ability to communicate with others to exchange information • Clear and conceptual thinking, judgment, troubleshooting, problem-solving, analysis, discretion, stress management, multitasking, and deadline management

🏖️ Benefits

• Remote office environment • Ability to travel up to 25% • Reasonable accommodations may be made upon request • Diverse and inclusive work environment • Equal-opportunity employment

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