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:
- Manage investigator site relationships to ensure effective delivery of clinical trials.
- Monitor site level adverse events and serious adverse events.
- Conduct onsite, remote, or electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.
- Submit all required reports, documentation, updates, and tracking within required timeframes.
- Identify and resolve investigator site issues within required timeframes.
- Resolve data queries within required timelines.
- Ensure adequate oversight of the investigational product at the investigator site.
Qualifications:
- 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.
- 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.
Physical/Mental Requirements:
- Advanced knowledge of clinical research and development processes.
- Demonstrated knowledge of global and local regulatory requirements.
- Advanced understanding of key operational elements of clinical research.
- Proven ability to work in a matrix team environment.
Non-Standard Work Schedule, Travel, or Environment Requirements:
- Significant travel (60-80%) within the area is required.
- Valid passport required.
Organizational Relationships:
- Partners with Site Care Partner and Country SOM.
- Reports to Director of Clinical Site Operations, or Director of Site Management and Monitoring, or Site Care Partner III.