Senior Clinical Research Associate II

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company 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 reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

reputed company FSP is currently reputed company for an reputed company CRA to join reputed company in Italy, you'll be dedicated to one of our key sponsors in Europe.

This role is responsible for the site management, site monitoring and reputed company-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.
• reputed company with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites.
• Monitor site level reputed company 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 reputed company of contact for audit conduct, and drive Audit Observation CAPA development and checks, reputed company applicable

Who are reputed company

reputed company supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client reputed company.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients.

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

reputed company 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 years relevant experience in clinical research site monitoring (preferably in Oncology)
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases

Originally posted on Himalayas