About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The Iovance TIL platform spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit www.iovance.com.

Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on www.iovance.com.

Overview

The Senior Clinical Research Associate is a critical in-house position within Iovance’s clinical team. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will provide operational management and daily oversight of study timelines, deliverables, and the performance of the Contract Research Organization (CRO) and study vendors, with site activity overseen remotely (and occasionally on site) through CRO monitoring reports and metrics. The Sr. CRA will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on-time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and company SOPs.

Essential Functions and Responsibilities

Independently manages the study start up activities for multi-center, US and/or global based studies.
Reviews and tracks CRO monitoring visit reports, follow-up letters, and action items; assesses site and CRA performance trends and escalates issues to the CTM
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports, including KPI/KRI review, enrollment and site activation tracking, and follow-up on protocol deviations and issue resolution.
Supports clinical site and CRO training by reviewing training materials and tracking training completion, and oversees site adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs through CRO reports and metrics.
Leads or participates in day-to-day vendor management activities (e.g., Central Laboratory, Central Imaging, CRO) including deliverable and timeline tracking, change orders, and invoice and budget reconciliation support
Performs in-house routine data listings review
Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
Serves as CTM delegate and partners with 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; contributes to study timelines, risk logs, and meeting agendas and minutes.
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.