CRA & CTA - Pharmaceutical Consultancy - Hays (Castilla-La Mancha)

Clinical Research & Technical Associate (CRA/CTA)

We are seeking a Clinical Research & Technical Associate (CRA/CTA) to join a dynamic, science-driven consulting environment. This role combines on-site monitoring responsibilities with essential administrative and documentation support across the full lifecycle of observational studies.

Key Responsibilities

Study Start-Up & Regulatory Affairs

• Prepare, compile, and submit study documentation to Ethics Committees (CEIm) and relevant regulatory authorities in accordance with applicable legislation (e.g., Royal Decree 957/2020, GDPR).
• Draft, review, and track contracts, amendments, and informed consent forms.
• Coordinate site initiation activities, including preparation of study start-up packages and Investigator Site Files (ISF).
• Liaise with regulatory bodies to ensure timely approvals and ongoing compliance.

Document Management

• Maintain and ...