Senior Oncology CRA — Site Monitoring & Study Oversight

IQVIA

Manchester

On-site

GBP 42,000 - 62,000

Full time

6 days ago
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Job summary

IQVIA is hiring for an on-site Clinical Research Associate to monitor sites for oncology studies in Manchester. You will ensure adherence to GCP/ICH guidelines, manage site communications, and support recruitment planning and data integrity across multiple sites.

The role requires 3–4 years of monitoring experience, a scientific/healthcare degree, and strong English communication. Familiarity with TMF/ISF, regulatory submissions, and study documentation is essential.

Qualifications

  • Bachelor’s Degree in scientific discipline or health care (preferred).
  • Minimum of 3–4 years of on-site monitoring experience.
  • Experience monitoring Oncology studies is a must.
  • Knowledge of GCP and ICH guidelines and regulatory requirements.
  • Proficient in Microsoft Word, Excel and PowerPoint; familiarity with laptop/iPhone/iPad.
  • Strong written and verbal English communication; good organizational skills.

Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements (GCP/ICH).
  • Collaborate with sites to drive and track subject recruitment plans to enhance predictability.
  • Administer protocol and study training to sites and maintain regular communication to manage expectations and issues.
  • Evaluate quality and integrity of site practices and escalate issues.
  • Track regulatory submissions, recruitment, CRF completion, data queries, and study progress; support start-up phase if needed.
  • Ensure site documents are filed in TMF and ISF maintained per regulations.
  • Document site management findings and action plans with visit reports and follow-up letters.
  • Collaborate with study team members for project execution support.

Education

Bachelor's Degree in scientific discipline or health care
On-site monitoring experience
Good knowledge of GCP/ICH guidelines
Written and verbal communication skills in English
Organizational and problem-solving skills
Time and financial management skills
Ability to establish and maintain effective working relationships

Tools

Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Laptop computer
iPhone
iPad

Job description

IQVIA is hiring for an on-site Clinical Research Associate to monitor sites for oncology studies in Manchester. You will ensure adherence to GCP/ICH guidelines, manage site communications, and support recruitment planning and data integrity across multiple sites.

The role requires 3–4 years of monitoring experience, a scientific/healthcare degree, and strong English communication. Familiarity with TMF/ISF, regulatory submissions, and study documentation is essential.

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