Clinical Research Associate / Senior - FSP - Remote

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 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