Parexel is looking for a Clinical Research Associate II/Senior Clinical Research Associate to ensure quality study execution and patient safety through expert site management and monitoring. You will be responsible for assigned clinical trial investigator sites, managing operational aspects from site activation through database lock to meet timelines and quality deliverables.
What You'll Do
- Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable laws and Good Clinical Practices.
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through database lock.
- Interface with the study team, 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.
- Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable.
What We're Looking For
- 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.
- Minimum 3 years relevant experience in clinical research site monitoring.
Nice to Have
- Monitoring experience preferably in Oncology.
- Therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases.
Team & Environment
You will be a member of the wider team, interfacing with the study team and vendors.
Work Mode
This is a fully remote position open to candidates within the European Union.
Parexel is committed to making a difference with a deep conviction in improving the world's health and taking work personally with empathy.
