Sr. CRA 1 - Single Sponsor Dedicated

Overview

In this role you will lead monitoring and site management to ensure studies are conducted per protocol and regulatory requirements. You will collaborate with sites and study teams to drive recruitment, training, and data quality, while safeguarding TMF and ISF documentation. You’ll monitor regulatory submissions, site performance, and issue resolution, contributing to project timelines and study integrity. This position offers exposure to global clinical trials and cross-functional collaboration within a sponsor-dedicated IQVIA service line. You will be part of a quality‑driven, compliance‑focused environment that aims to improve patient outcomes and support study success.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive and track subject recruitment plans aligned with project needs.
• Administer protocol training to sites and maintain regular communication to manage expectations.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues as needed.
• Manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data queries; may support start-up.
• Ensure TMF and ISF documentation are maintained per GCP and local requirements.
• Create and maintain site management documentation, visit reports, and follow-up communications.
• Collaborate with study team members for project execution support.
• Support development of per-site recruitment plans; possibly assist with site financial management and invoicing as applicable.

Key requirements

• Bachelor's Degree in scientific discipline or health care (preferred)
• ≥2 years on-site monitoring experience
• Good knowledge of GCP and ICH guidelines
• Therapeutic and protocol knowledge from company training
• Proficiency in Microsoft Word, Excel, PowerPoint; use of laptop, iPhone and iPad where applicable
• Excellent written and verbal English communication
• Strong organizational and problem-solving abilities
• Effective time and financial management
• Ability to build and maintain relationships with coworkers, managers, and clients
• Visit the role is not eligible for UK visa sponsorship

• strong communication
• organizational skills
• problem-solving
• GCP
• ICH guidelines
• site monitoring

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