Clinical Research Associate / Senior - FSP - Remote

ppParexel 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. /ppThis 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 /ph3Some Specifics About This Advertised Role /h3ulliEnsure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices. /liliManage 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. /liliInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites. /liliMonitor 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. /liliServe as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable /li /ulh3Who Are Parexel /h3pParexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base. /ppWe 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. /ppYou’ll be an influential member of the wider team. /ph3What We Are Looking For In This Role /h3pFor every role, we look for professionals who have the determination and courage always to put patient well-being first. /ppThat to us is working with heart. /ph3Here are a few requirements specific to this advertised role /h3ulliBachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent /liliExtensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations /liliMonitoring Experience: Minimum 3.5 years relevant experience in clinical research site monitoring (preferably in Oncology) /liliPreferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases /li /ul /p #J-18808-Ljbffr