Senior Clinical Research Associate

The role

The Senior Clinical Research Associate provides operational management and daily oversight of study timelines, deliverables, and vendor performance. This in-house role involves monitoring site activity remotely and occasionally on site to ensure compliance with regulatory requirements and GCP guidelines.

What you will do

• Manages 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.
• Provides monitoring oversight by reviewing monitoring schedules, metrics, and reports.
• Supports clinical site and CRO training and oversees site adherence to protocol.
• Leads or participates in day-to-day vendor management activities.
• Performs in-house routine data listings review.
• Collects, reviews, and monitors required regulatory documentation.
• Serves as CTM delegate and partners with cross-functional representatives.
• Mentors and coaches junior staff.
• Assists with the development of protocol writing, informed consent, and other study documents.

Required qualifications

• BS/BA, RN, or equivalent
• 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
• 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 MS Word, PowerPoint, Excel and Project
• Ability to remain in a stationary position standing or sitting for prolonged periods of time

Nice to have

• Prior on-site monitoring (CRA) experience
• Experience with eTMF and CTMS systems
• Experience with tracking CRO/vendor budgets and invoices

About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with centralized U.S.-based manufacturing.