CRA II – Oncology Site Monitoring & Trial Execution

IQVIA Inc; Manchester; On-site; GBP 45,000 - 65,000; Full time

Job summary

IQVIA Biotech is seeking an on-site Monitoring professional to ensure high-quality conduct of oncology protocols and regulatory compliance across assigned sites. You will train and support site staff, manage recruitment plans, and coordinate with the study team to drive project success.

The role requires 1 year of CRA experience, strong knowledge of GCP/ICH guidelines, and excellent communication and organizational skills in English.

Qualifications

• Minimum 1 year 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 Good Clinical Practice (GCP) and ICH guidelines.
• Strong knowledge of protocols and therapy areas as provided in training.
• Proficiency in Word, Excel and PowerPoint; ability to use a laptop and mobile devices.
• Written and verbal communication skills in English.
• Organizational and problem-solving abilities.
• Effective time and financial management; ability to collaborate with study teams.

Responsibilities

• Perform site monitoring visits in compliance with GCP/ICH and contract scope.
• Work with sites to drive subject recruitment plans to enhance predictability.
• Administer protocol-related training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Ensure TMF and ISF documents are properly filed and up to date.
• Create and maintain documentation on site management, visits and actions.
• Collaborate with study team members for project execution support.
• May support start-up phase and per-site recruitment plans as applicable.
• May manage site finances according to trial agreements and invoicing rules.

Skills

On-site monitoring

GCP/ICH knowledge

Therapeutic/protocol knowledge

English communication

Organizational skills

Time management

Relationship building

Education

Bachelor's Degree in scientific discipline or health care

Tools

MS Office

Job description

IQVIA Biotech is seeking an on-site Monitoring professional to ensure high-quality conduct of oncology protocols and regulatory compliance across assigned sites. You will train and support site staff, manage recruitment plans, and coordinate with the study team to drive project success.

The role requires 1 year of CRA experience, strong knowledge of GCP/ICH guidelines, and excellent communication and organizational skills in English.