About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.
The Senior Clinical Research Associate is responsible for monitoring and managing sites based in Portugal.
Please, keep in mind that this is a Freelance role for only 0.2 FTE.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.
Key Responsibilities
- Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the applicable monitoring plan
- Oversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issues
- Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
- Review and maintain study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulations
- Collaborate cross-functionally with medical, project management, quality management, and data management teams, and support sites during audits and inspections
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