Senior Oncology CRA - Site Monitoring & Oversight

IQVIA LLC; East Boldon; On-site; GBP 42,000 - 65,000; Full time

Job summary

IQVIA Biotech is seeking an experienced Clinical Site Monitor to conduct on-site visits for oncology studies in strict accordance with GCP/ICH guidelines, ensuring data integrity and regulatory compliance.

You will collaborate with study teams to adapt recruitment plans, administer protocol training, manage documentation and communicate effectively with sites. The role may involve site financial oversight and TMF/ISF management.

Qualifications

• Minimum 3-4 years of on-site monitoring experience.
• Experience monitoring Oncology studies is a must.
• Bachelor’s Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Basic knowledge of GCP and ICH guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Word, Excel and PowerPoint and use of a laptop/iPhone/iPad where applicable.
• Written and verbal communication skills including good command of English.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with contracted scope and GCP/ICH.
• Drive and track subject recruitment plan to enhance predictability.
• Administer protocol training and maintain regular site communications.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
• Maintain TMF/ISF documents and related filings.
• Submit visit reports and follow-up letters; develop action plans.
• Collaborate with study team for project execution support.
• Support development of recruitment plans per site; may assist site financial management.

Skills

GCP/ICH knowledge

On-site monitoring

Recruitment plan execution

Regulatory tracking

English communication

Project coordination

Time & financial management

Education

Bachelor’s Degree in science/healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA Biotech is seeking an experienced Clinical Site Monitor to conduct on-site visits for oncology studies in strict accordance with GCP/ICH guidelines, ensuring data integrity and regulatory compliance.

You will collaborate with study teams to adapt recruitment plans, administer protocol training, manage documentation and communicate effectively with sites. The role may involve site financial oversight and TMF/ISF management.