Senior Clinical Research Associate - Sponsor Dedicated - Oncology Experience Needed

Parexel; Uxbridge; On-site; GBP 45,000 - 60,000; Full time

Job summary

Parexel in Uxbridge is seeking an experienced Senior Clinical Research Associate (CRA) to manage clinical trials and ensure patient safety. This role involves overseeing site management, monitoring compliance with clinical practices, and ensuring quality deliverables throughout the study.

The ideal candidate has a Bachelor’s degree in life sciences and at least 3.5 years of relevant clinical research experience, ideally in Oncology. Join Parexel and become a vital part of a team committed to exceptional patient care.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or medical background.
• Extensive knowledge of clinical trial methodologies and ICH/GCP.
• Minimum 3.5 years of experience in clinical research site monitoring.

Responsibilities

• Ensure conduct of clinical trials in accordance with regulations.
• Manage operational aspects of clinical trial activities.
• Monitor site level AEs and SAEs, ensuring resolutions.

Skills

Clinical trial methodologies

ICH/GCP

Monitoring experience

Knowledge of FDA regulations

Education

Bachelor’s degree in life sciences

Job description

Parexel FSP is hiring for an experienced Senior CRA level to join one of a large Sponsor’s in the EU.

This role is responsible for the site management, site monitoring and close‑out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.

Some Specifics About This Advertised Role

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock, ensuring relevant timelines and quality deliverables are met.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow‑up with investigators sites, as needed, to bring SAE reports required information to resolution.
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks when applicable.

Who Are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best‑selling drugs, but equally we enable more niche drug developments that are critical to the well‑being of many patients.

You’ll be an influential member of the wider team.

What We Are Looking For In This Role

For every role, we look for professionals who have the determination and courage always to put patient well‑being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Monitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases