Senior Clinical Research Associate

Parexel International; United Kingdom; Remote; GBP 60,000 - 90,000; Full time

Job summary

Parexel FSP is seeking an experienced Senior CRA to join a large Sponsor’s EU project. The role focuses on site management, monitoring and close-out of investigator sites to ensure patient safety and high-quality study execution.

Key responsibilities include site activation through database lock, adherence to monitoring plans, and collaboration with study teams, vendors and Drug Safety for SAE follow-up. Oncology experience is preferred.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations.
• Monitoring Experience: minimum 3.5 years in clinical research site monitoring (Oncology preferred).
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases.

Responsibilities

• Site management, site monitoring and close-out of investigator sites to ensure patient safety and quality.
• Ensure adherence to Study Monitoring Plan and prevailing laws, GCP, and regulatory requirements.
• Manage operational aspects from site activation through database lock, meeting timelines and quality deliverables.
• Interface with study team, vendors and sites to facilitate information flow.
• Monitor site-level AEs/SAEs and coordinate with Drug Safety for SAE resolution.

Skills

Clinical trial methodologies

ICH/GCP

FDA regulations

Local country regulations

Education

Bachelor’s degree in life sciences (or nursing/pharmacy/medical background)

Job description

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

Some specifics about this advertised role

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

• 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