# Biotech Site Monitor

**Company**: IQVIA
**Location**: Reading, Berkshire
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/CRA-2--IQVIA-Biotech_R1574198?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_00bb041e-8a6

## Description

Join IQVIA Biotech, where innovation meets impact.

At IQVIA Biotech, we specialise in partnering with smaller biotech and emerging biopharma companies, creating a uniquely dynamic and fast-paced environment. You'll gain early insights into groundbreaking therapies and novel diseases, often before they reach the broader scientific community.

**Responsibilities**

- Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

- Work with sites to adapt, drive and track subject recruitment plans to enhance predictability.

- Administer protocol and related study training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.

- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form completion and submission, and data query generation and resolution.

- Ensure site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP/ICH and local regulatory requirements.

- Create and maintain documentation regarding site management, monitoring visit findings and action plans.

- Collaborate with study team members for project execution support.

**Qualifications**

- Minimum of 1 year of on-site monitoring experience.

- Experience monitoring Oncology studies is essential.

- Bachelor's Degree in a scientific discipline or healthcare preferred.

- Basic knowledge of and skill in applying applicable clinical research regulatory requirements (GCP and ICH guidelines).

- Good therapeutic and protocol knowledge as provided in company training.

- Computer skills including proficiency in Microsoft Word, Excel and PowerPoint.

- 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.

**Additional Information**

This role is not eligible for UK visa sponsorship. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud.

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## Skills

### Required
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH)
- Microsoft Word
- Excel
- PowerPoint
- Oncology studies
- English

### Nice to have
- Bachelor's Degree in scientific discipline or healthcare

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Reading-Berkshire-United-Kingdom/CRA-2--IQVIA-Biotech_R1574198?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)