Senior Clinical Research Associate

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Senior Clinical Research Associate is a critical position within Iovance’s clinical team. In close collaboration with the Clinical Trial Manager and/or Study Director, the Sr. CRA will work to manage and provide daily operational oversight of Contract Research Organization (CRO), study vendors, and clinical trial sites. 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.
• 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.

Travel

• Ability to travel up to 25%

Required Education, Skills, and Knowledge

• 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
• 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

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

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Originally posted on Himalayas