About this role

TFS HealthScience is a leading integral 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 the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements.

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- Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.- Verify proper management and accountability of Investigational Product
- Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings,



corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
- Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
- Timely delivering site documents to eTMF or paper TMF.
- Verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.

Qualifications
- Bachelor’s Degree, preferably in life science or nursing; or equivalent
- 4 years of experience as CRA including relevant on-site monitoring experience.
- Able to work in a fast-paced environment with changing priorities.
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines.

What W

📌 Senior Clinical Research Associate (Barcelona)
🏢 TFS HealthScience
📍 Barcelona