Clinical Research Associate​/Senior - FSP - Remote

Position: Clinical Research Associate / Senior - FSP - Remote Location: Town of Italy Clinical Research Associate / Senior - FSP - Remote Join to apply for the Clinical Research Associate / Senior - FSP - Remote role at Parexel . 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 investigator 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. 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. Seniority level Mid‑Senior level Employment type Full‑time Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care #J-18808-Ljbffr Apply tot his job Apply To this Job