ParexelSenior CRA - Italian and Spanish Speaking - Remote - FSP
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is hiring an experienced Senior CRA level to join one of our key sponsors in the EU. In this role you will monitor at sites across both Italy and Spain.
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
Must have experience monitoring across both Italy and Spain
English, Italian and Spanish language skills are essential