Overview
In this Senior CRA role, you will oversee site management, monitoring, and close-out for assigned investigative sites to safeguard patient safety and ensure high-quality study execution. You’ll manage operational activities from site activation to database lock and coordinate with cross-functional teams to maintain timelines. You will monitor AEs/SAEs and support audit processes, driving CAPA where needed. Join Parexel FSP to contribute to clinical development that benefits patients while working with a collaborative sponsor team.
Responsibilities
- Manage site activation, monitoring, and close-out for investigator sites
- Ensure trial conduct adheres to the Study Monitoring Plan, ICH/GCP, FDA and local regulations
- Coordinate with study team, vendors, and sites to ensure timely, quality deliverables
- Monitor site-level AEs/SAEs and liaise with Drug Safety Unit for resolution
- Act as point of contact for audits and drive CAPA development and checks
Key requirements
- 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 in clinical research site monitoring (preferably Oncology)
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
- patient-centric mindset
- collaborative communication
- proactive information flow and coordination
- clinical trial methodologies
- ICH/GCP and FDA regulations
- site monitoring and CAPA processes
Senior Clinical Research Associate in London employer: PAREXEL
At Parexel, we pride ourselves on being an exceptional employer, offering a collaborative work culture that fosters innovation and professional growth. Our team members enjoy competitive benefits, including flexible working arrangements and opportunities for career advancement, all while contributing to impactful global clinical trials in a supportive environment across the UK, Poland, Serbia, and Hungary.
