Clinical Research Associate

TFS HealthScience

Lisbon, Portugal

About the Role

As a Senior Clinical Research Associate with TFS HealthScience, you will be an integral part of our SRS/FSP team, collaborating with a global pharmaceutical/biotech sponsor. Your role will involve overseeing clinical trials to ensure their quality, integrity, and progress.

Key Responsibilities

Submission & Amendment Support: Assist with submissions and amendments to ethics committees.
Regulatory Reporting: Manage periodic reporting to ethics committees, including safety event notifications.
Site Activation & Support: Contribute to site activation activities and support Site Initiation Visits (SIVs).
Monitoring & Site Management: Conduct onsite and remote monitoring to ensure trial compliance; maintain effective site relationships.
Documentation & Closeout: Ensure proper maintenance of trial documentation and lead closeout activities.

Qualifications

Experience: Clinical trial monitoring experience within a CRO, biotech, or pharmaceutical environment.
Education: Degree in a related field (e.g., Life Sciences, Nursing, or equivalent).
Regulatory Knowledge: Familiarity with ICH-GCP guidelines and local regulatory requirements.
Technical Skills: Basic proficiency in clinical trial management systems (CTMS) and eTMF platforms.
Communication: Strong written and verbal communication skills in English.

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