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IQVIA

CRA 2

IQVIA

. Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and regulatory requirements .

Posted 11/4/2026full-timeReading • United KingdomJuniorWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in site monitoring for clinical trials, particularly in Oncology studies, while ensuring compliance with regulatory requirements such as GCP and ICH guidelines. Proficient in managing project expectations, recruitment plans, and maintaining effective communication with study sites.

Highest-signal resume keywords
On-Site Monitoring ExperienceOncology Studies MonitoringGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Microsoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Site MonitoringProtocol AdministrationRegulatory Submissions TrackingData Query GenerationTrial Master File ManagementCRF CompletionStudy TrainingSite Finances ManagementRecruitment Plan TrackingQuality Evaluation
Soft Skills
Written CommunicationVerbal CommunicationOrganizational SkillsProblem-Solving SkillsTime Management
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointLaptop ComputerIPhoneIPad
Industry Keywords
Clinical ResearchRegulatory RequirementsTherapeutic KnowledgeSite ManagementProject Execution

About the role

Key responsibilities & impact
  • Perform site monitoring visits, including selection, initiation, monitoring and close-out visits, in accordance with contracted scope of work and regulatory requirements
  • Work with sites to adapt, drive and track subject recruitment plans
  • Administer protocol and related study training to assigned sites
  • Establish regular communication with sites to manage project expectations and issues
  • Evaluate study site practices for protocol quality, integrity and regulatory adherence; escalate quality issues
  • Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
  • Support study start-up activities where applicable
  • Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance
  • Maintain documentation of site management, monitoring findings and action plans, including visit reports and follow-up letters
  • Collaborate with study team members to support project execution
  • Support site-level subject recruitment plans where applicable
  • Manage site finances according to clinical trial agreements and retrieve invoices according to local requirements where applicable

Requirements

What you’ll need
  • Minimum of 1 year of experience of on-site monitoring experience
  • Experience monitoring Oncology studies is a must
  • Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
  • Good therapeutic and protocol knowledge as provided in company training
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone and iPad (where applicable)
  • Written and verbal communication skills including good command of English language
  • Organizational and problem-solving skills
  • Effective time and financial management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
  • This role is not eligible for UK visa sponsorship