Senior Clinical Research Associate

About   the company the company, Inc.

The company , 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  the company 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, the company 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  [link for members] .

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

Information on the company’s broad, industry-leading patent portfolio is available on the Intellectual Property page on  [link for members] .

Overview

The Senior Clinical Research Associate is a critical in-house position within the company’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.

• Maintains and performs quality review of the Trial Master File (TMF) and supports inspection readiness activities.

• Contributes to the development and maintenance of study-level plans (e.g., monitoring, communication, risk management) and to clinical operations process and SOP improvement.

• Prepares study status updates and presentations for clinical leadership and cross-functional study team meetings.

• 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 the company’ 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 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

• Must have experience in Solid Tumor or Cell Therapy

• Prior on-site monitoring (CRA) experience is a plus but not required

• 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

• Experience with eTMF and CTMS systems and with tracking CRO/vendor budgets and invoices preferred

• 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.

#li-remote

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

Pay Transparency

$130,000 — $150,000 USD

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

The company is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [link for members] .

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