Description
The Senior Clinical Research Associate I is responsible for site management, site monitoring, and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution.
Responsibilities include:
- Managing investigator site relationships to ensure effective delivery of clinical trials
- Ensuring quality of investigator sites, patient safety, and site quality and compliance with GCP
- Resolving protocol-related issues for assigned investigator sites
- Conducting onsite, remote, or electronic monitoring as needed
- Providing enrollment support and ensuring progress
- Monitoring site-level AEs and SAEs and collaborating with the Drug Safety Unit
- Submitting required reports, documentation, updates, and tracking within required timeframes
- Identifying and resolving investigator site issues within required timeframes
- Ensuring adequate oversight of the investigational product at the investigator site
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
- Minimum 3 years relevant experience in clinical research site monitoring, preferably 2 years in Oncology
- Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases
- Global clinical trial experience
- Fluency in English and the native language(s) of the country they will work in