Clinical Research Associate II / Senior Clinical Research Associate - Remote - FSP - Register Y[...]

Parexel; Paris; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A clinical research organization is seeking CRA II and Senior CRA professionals to manage clinical trial investigator sites. Candidates must have a degree in life sciences and extensive knowledge of clinical trial methodologies. This role includes responsibilities for site management, monitoring, and ensuring patient safety throughout the trial process. Experience in Oncology is preferred.

Qualifications

• Minimum 3 years of relevant experience in clinical research site monitoring.
• Experience in Oncology or related therapeutic areas preferred.

Responsabilités

• Ensure proper conduct of clinical trials as per regulations.
• Manage operational aspects for clinical trial activities.
• Monitor site-level Adverse Events (AEs) and Serious AEs (SAEs).

Connaissances

Knowledge of clinical trial methodologies

Understanding of ICH/GCP

Regulatory knowledge (FDA, local regulations)

Formation

Bachelor’s degree in life sciences or related field

Description du poste

When our values align, there's no limit to what we can achieve.

Parexel FSP will soon begin recruiting for CRA II and Senior CRA roles to join one of a large Sponsor’s in the EU.

This role is responsible for site management, site monitoring, and close-out of assigned clinical trial 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 laws, Good Clinical Practices.
• Manage operational aspects for clinical trial activities at investigator sites from site activation through database lock, ensuring timelines and quality deliverables are met.
• Interface with the study team, facilitate information flow between team members, vendors, and investigator sites.
• Monitor site-level AEs and SAEs, collaborate with the Drug Safety Unit, and follow-up with investigator sites to resolve SAE reports.
• Serve as a point of contact for audits and drive CAPA development and checks for audit observations.

Who are Parexel

Parexel supports clinical studies across various therapeutic areas and has longstanding partnerships with a diverse client base.

We supported trials for most of today’s top 50 best-selling drugs and enable niche developments critical to patient well-being.

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

What we are looking for in this role

We seek professionals committed to always prioritizing patient well-being — working with heart.

Here are some specific requirements for this role:

• Bachelor’s degree in life sciences or a professional degree such as nursing, pharmacy, or medical background, or equivalent.
• Extensive knowledge of clinical trial methodologies, ICH / GCP, FDA, and local regulations.
• Minimum 3 years of relevant experience in clinical research site monitoring, preferably in Oncology.
• Experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases is preferred.