Clinical Research Associate / Senior - FSP - Remote

Parexel; Italia; In loco; EUR 52.000 - 76.000; Tempo pieno

Descrizione del lavoro

Parexel is hiring two experienced CRAs at the CRA II or Senior CRA level to join a large Sponsor in the EU. The role encompasses site management, site monitoring and trial close-out to ensure patient safety and high-quality study execution.

Key responsibilities include monitoring according to the study plan, coordinating activities across the study team and vendors, and handling AEs/SAEs with the Drug Safety Unit as needed. Oncology experience is preferred.

Competenze

• Bachelor's degree in life sciences or equivalent required.
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations.
• Minimum 3.5 years of site monitoring experience, preferably in Oncology.

Mansioni

• Manage site monitoring and close-out of assigned trials to ensure patient safety and quality.
• Ensure trial conduct conforms with monitoring plans and applicable laws.
• Coordinate information flow between study team, vendors and investigator sites.
• Monitor AEs/SAEs and support SAE resolution with Drug Safety.

Conoscenze

Site management

Site monitoring

GCP/ICH

Oncology experience

Regulatory knowledge

Formazione

Bachelor's degree in Life Sciences

Strumenti

CTMS

EDC

Descrizione del lavoro

Parexel FSP is hiring for two experienced CRA's at either the CRA II or 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